🔍 RecallPedia

Zimmer Manufacturing B.V.

91 recalls •
🏥 Medical Devices
• Categories: Other Medical Devices, Diagnostic Equipment, Infusion Pumps, Implants & Prosthetics

Zimmer Plates and Screws (ZPS) 4.0 mm Cancellous Screw Fully Threaded, 12 mm Length 47484001200 4.0 mm Cancellous Screw Fully Threaded, 14 mm Length 47484001400 4.0 mm Cancellous Screw Fully Threaded, 16 mm Length 47484001600 4.0 mm Cancellous Screw Fully Threaded, 18 mm Length 47484001800 4.0 mm Cancellous Screw Fully Threaded, 20 mm Length 47484002000 4.0 mm Cancellous Scrwe Fully Threaded, 22 mm Length 47484002200 4.0 mm Cancellous Screw Fully Threaded, 26 mm Length 47484002600 4.0 mm Cancellous Screw Fully Threaded, 30 mm Length 47484003001 4.0 mm Cancellous Screw Fully Threaded, 32 mm Length 47484003200 4.0 mm Cancellous Screw Fully Threaded, 36 mm Length 47484003600 4.0 mm Cancellous Screw Fully Threaded, 40 mm Length 47484004000 4.0 mm Cancellous Screw Fully Threaded, 45 mm Length 47484004500 4.0 mm Cancellous Screw Fully Threaded, 50 mm Length 47484005000 4.0 mm Cancellous Screw Fully Threaded, 55 mm Length 47484005500 4.0 mm Cancellous Screw Fully Threaded, 60 mm Length 47484006000 4.5 mm Cortical Screw SelfTapping, 16 mm Length 47484501601 4.5 mm Cortical Screw SelfTapping, 18 mm Length 47484501801 4.5 mm Cortical Screw Self-Tapping, 20 mm Length 47484502001 4.5 mm Cortical Screw Self-Tapping, 22 mm Length 47484502201 4.5 mm Cortical Screw SelfTapping, 24 mm Length 47484502401 4.5 mm Cortical Screw SelfTapping, 26 mm Length 47484502601 4.5 mm Cortical Screw SelfTapping, 28 mm Length 47484502801 4.5 mm Cortical Screw SelfTapping, 34 mm Length 47484503401 4.5 mm Cortical Screw SelfTapping, 38 mm Length 47484503801 4.5 mm Cortical Screw SelfTapping, 40 mm Length 47484504001 4.5 mm Cortical Screw SelfTapping, 42 mm Length 47484504201 4.5 mm Cortical Screw SelfTapping, 54 mm Length 47484505401 4.5 mm Cortical Screw Self-Tapping, 58 mm Length 47484505801 4.5 mm Cortical Screw SelfTapping, 64 mm Length 47484506401 4.5 mm Cortical Screw SelfTapping, 66 mm Length 47484506601 4.5 mm Cortical Screw SelfTapping, 68 mm Length 47484506801 4.5 mm Cortical Screw SelfTapping, 70 mm Length 47484507001 6.5 mm Cancellous Screw Fully Threaded, 45 mm Length 47486504500 6.5 mm Cancellous Screw Fully Threaded, 55 mm Length 47486505500 6.5 mm Cancellous Screw Fully Threaded, 60 mm Length 47486506000 6.5 mm Cancellous Screw, 32 mm Thread Length, 60 mm Length 47486506002 6.5 mm Cancellous Screw Fully Threaded, 65 mm Length 47486506500 6.5 mm Cancellous Screw, 32 mm Thread Length, 65 mm Length 47486506502 6.5 mm Cancellous Screw Fully Threaded, 70 mm Length 47486507000 6.5 mm Cancellous Screw, 16 mm Thread Length, 80 mm Length 47486508001 6.5 mm Cancellous Screw, 32 mm Thread Length, 80 mm Length 47486508002 6.5 mm Cancellous Screw, 32 mm Thread Length, 85 mm Length 47486508502

Class I - Dangerous

A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.

May 4, 2016 Other Medical Devices Nationwide View Details →

Hgp ii acetabular cup bone screw selftap 6.5x15mm 00662406515 Hgp ii acetabular cup bone screw selftap 6.5x20mm 00662406520 Hgp ii acetabular cup bone screw selftap 6.5x25mm 00662406525 Hgp ii acetabular cup bone screw selftap 6.5x35mm 00662406535 Hgp ii acetabular cup bone screw selftap 6.5x55mm 00662406550 Hgp ii acetabular cup bone screw selftap 6.5x60mm 00662406560

Class I - Dangerous

A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.

May 4, 2016 Other Medical Devices Nationwide View Details →

Zimmer Plates and Screws (ZPS) 3.5 mm Cortical Screw SelfTapping, 10 mm Length 47483501001 3.5 mm Cortical Screw SelfTapping, 14 mm Length 47483501401 3.5 mm Cortical Screw SelfTapping, 16 mm Length 47483501601 3.5 mm Cortical Screw SelfTapping, 24 mm Length 47483502401 3.5 mm Cortical Screw SelfTapping, 30 mm Length 47483503001 3.5 mm Cortical Screw SelfTapping, 40 mm Length 47483504001 3.5 mm Cortical Screw SelfTapping, 75 mm Length 47483507501

Class I - Dangerous

A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.

May 4, 2016 Other Medical Devices Nationwide View Details →

Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Fully Threaded, 5.0 mm Diameter, 20 mm Length 00114205020 Mini Magna-Fx Cannulated Screw Fixation System Small Cannulated Bone Screw, Fully Threaded, 5.0 mm Diameter, 36 mm Length 00114205036 Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Partially Threaded, 5.0 mm Diameter, 24 mm Length 00114205124 Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Partially Threaded, 5.0 mm Diameter, 28 mm Length 00114205128 Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Partially Threaded, 5.0 mm Diameter, 30 mm Length 00114205130 Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Partially Threaded, 5.0 mm Diameter, 38 mm Length 00114205138 Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Partially Threaded, 5.0 mm Diameter, 48 mm Length 00114205148 Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Partially Threaded, 5.0 mm Diameter, 65 mm Length 00114205165 MagnaFx Cannulated Screw Fixation System Cannulated Bone Screw, Fully Threaded, 7.0 mm Diameter, 55 mm Length 00114605599 MagnaFx Cannulated Screw Fixation System Cannulated Bone Screw, Fully Threaded, 7.0 mm Diameter, 60 mm Length 00114606099 MagnaFx Cannulated Screw Fixation System Cannulated Bone Screw, 32 mm Thread Length, 7.0 mm Diameter, 65 mm Length 00114606532 MagnaFx Cannulated Screw Fixation System Cannulated Bone Screw, Fully Threaded, 7.0 mm Diameter, 65 mm Length 00114606599 Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Fully Threaded, 5.0 mm Diameter, 12 mm Length 00114205012

Class I - Dangerous

A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.

May 4, 2016 Diagnostic Equipment Nationwide View Details →

Product 25 consists of all product under product code: LPH and same usage: Item no: 234703104 DISTAL MEDIAL FEMORAL CON 234703206 DISTAL MEDIAL FEMORAL CON 234703208 DISTAL MEDIAL FEMORAL CON 234800504 DISTAL POSTERIOR/LATERAL 234800506 DISTAL POSTERIOR/LATERAL 234800508 DISTAL POSTERIOR/LATERAL 234800510 DISTAL POSTERIOR/LATERAL 234800604 DISTAL POSTERIOR/LATERAL 234800606 DISTAL POSTERIOR/LATERAL 234800608 DISTAL POSTERIOR/LATERAL 234800610 DISTAL POSTERIOR/LATERAL 234800614 DISTAL POSTERIOR/LATERAL For use in total hip arthroplasty

Class I - Dangerous

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Jan 11, 2016 Implants & Prosthetics Nationwide View Details →

Product 12 consists of all product under product code JDI , and same usage: Item no: 902602935 6 DEGREE COCR FEM HEAD 28 902602835 6 DEGREE COCR FEM HEAD 28 902603235 6 DEGREE COCR FEM HEAD 32 902603335 6 DEGREE COCR FEM HEAD 32 902603600 6 DEGREE COCR FEM HEAD 36 902603610 6 DEGREE COCR FEM HEAD 36 902603614 6 DEGREE COCR FEM HEAD 36 Product Usage: For use in total or hemi hip arthroplasty

Class I - Dangerous

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Jan 11, 2016 Implants & Prosthetics Nationwide View Details →

Product 31 consists of all product under product code: KTT and same usage: Item no: 118113003 FREE-LOCK TUBE & SCP PLAT 118113502 FREE-LOCK TUBE & SCP PLAT 118113503 FREE-LOCK TUBE & SCP PLAT 118114002 FREE-LOCK TUBE & SCP PLAT 118114003 FREE-LOCK TUBE & SCP PLAT 118114502 FREE-LOCK TUBE & SCP PLAT 118114503 FREE-LOCK TUBE & SCP PLAT 118115002 FREE-LOCK TUBE & SCP PLAT 118115003 FREE-LOCK TUBE & SCP PLAT Product Usage: Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Class I - Dangerous

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Jan 11, 2016 Implants & Prosthetics Nationwide View Details →

Product 52 consists of product code: HWC and same usage: Item no: 525004530 NEXGEN OSTEOTOMY CORT BON 525004540 NEXGEN OSTEOTOMY CORT BON 525006545 NEXGEN OSTEOTOMY CORT BON 525006560 NEXGEN OSTEOTOMY CORT BON 525006565 NEXGEN OSTEOTOMY CORT BON for use in total knee arthroplasty

Class I - Dangerous

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Jan 11, 2016 Implants & Prosthetics Nationwide View Details →

Product 18 consists of all product under product code: HWC and same usage: Item no: 47248001441 CANC SCR 4.0MM X 14MM FUL 47248001641 CANC SCR 4.0MM X 16MM FUL 47248001840 CANC SCR 4.0MM X 18MM 47248001841 CANC SCR 4.0MM X 18MM FUL 47248002041 CANC SCR 4.0MM X 20MM FUL 47248002441 CANC SCR 4.0MM X 24MM FUL 47248003641 CANC SCR 4.0MM X 36MM FUL Product Usage: A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Class I - Dangerous

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Jan 11, 2016 Implants & Prosthetics Nationwide View Details →

Product 5 consists of all products under product code HWC, and same usage: Item no: 47482701001 2.7MM CORT. SCREW 10MM, S 47482701201 2.7MM CORT. SCREW 12MM, S 47482701401 2.7MM CORT. SCREW 14MM, S 47482701601 2.7MM CORT. SCREW 16MM, S 47482701801 2.7MM CORT. SCREW 18MM, S 47482702001 2.7MM CORT. SCREW 20MM, S Product Usage: A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Class I - Dangerous

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Jan 11, 2016 Implants & Prosthetics Nationwide View Details →

Product 51 consists of all product under product code: JWH and same usage: Item no: 598603701 NEXGEN OPTION STEMMED TIB 598603702 NEXGEN OPTION STEMMED TIB 598604701 NEXGEN OPTION STEMMED TIB 598604702 NEXGEN OPTION STEMMED TIB 598605701 NEXGEN OPTION STEMMED TIB 598605702 NEXGEN OPTION STEMMED TIB for use in total knee arthroplasty

Class I - Dangerous

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Jan 11, 2016 Implants & Prosthetics Nationwide View Details →

Product 36 consists of all product under product code: HSB and same usage: Item no: 225302745 INTERLOCKING IM SCREW 4.5 225303045 INTERLOCKING IM SCREW 4.5 225303245 INTERLOCKING IM SCREW 4.5 225303545 INTERLOCKING IM SCREW 4.5 225303745 INTERLOCKING IM SCREW 4.5 225304045 INTERLOCKING IM SCREW 4.5 225304245 INTERLOCKING IM SCREW 4.5 225304545 INTERLOCKING IM SCREW 4.5 225305045 INTERLOCKING IM SCREW 4.5 225305245 INTERLOCKING IM SCREW 4.5 225305545 INTERLOCKING IM SCREW 4.5 225305745 INTERLOCKING IM SCREW 4.5 225306045 INTERLOCKING IM SCREW 4.5 225306545 INTERLOCKING IM SCREW 4.5 225307045 INTERLOCKING IM SCREW 4.5 Product Usage: An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.

Class I - Dangerous

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Jan 11, 2016 Implants & Prosthetics Nationwide View Details →

Product 17 consists of all product under product code: LPH and same usage: Item no: 625004515 BONE SCREW 4.5X15 SELF-TA 625004520 BONE SCREW 4.5X20 SELF-TA 625004525 BONE SCREW 4.5X25 SELF-TA 625004530 BONE SCREW 4.5X30 SELF-TA 625004535 BONE SCREW 4.5X35 SELF-TA 625004540 BONE SCREW 4.5X40 SELF-TA 625004550 BONE SCREW 4.5X50 SELF-TA 625006515 BONE SCREW 6.5X15 SELF-TA 625006520 BONE SCREW 6.5X20 SELF-TA 625006525 BONE SCREW 6.5X25 SELF-TA 625006530 BONE SCREW 6.5X30 SELF-TA 625006535 BONE SCREW 6.5X35 SELF-TA 625006540 BONE SCREW 6.5X40 SELF-TA 625006550 BONE SCREW 6.5X50 SELF-TA 625006560 BONE SCREW 6.5X60 SELF-TA 625006570 BONE SCREW 6.5X70 SELF-TA Product Usage: For use in total or hemi hip arthroplasty

Class I - Dangerous

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Jan 11, 2016 Implants & Prosthetics Nationwide View Details →

Product 45 consists of all product under product code: JWH and same usage: Item no: 511007020 MGII KNEE SLF-TAP BONE ST 511007025 MGII KNEE SLF-TAP BONE ST 511007030 MGII KNEE SLF-TAP BONE ST 511007035 MGII KNEE SLF-TAP BONE ST 511007040 MGII KNEE SLF-TAP BONE ST 511007045 MGII KNEE SLF-TAP BONE ST for use in total knee arthroplasty

Class I - Dangerous

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Jan 11, 2016 Implants & Prosthetics Nationwide View Details →

Product 59 consists of all product under product code: JWH and same usage: Item no: 42540000026 PSN ALL POLY PAT PLY 26MM 42540000029 PSN ALL POLY PAT PLY 29MM 42540000032 PSN ALL POLY PAT PLY 32MM 42540000035 PSN ALL POLY PAT PLY 35MM 42540000038 PSN ALL POLY PAT PLY 38MM 42540000041 PSN ALL POLY PAT PLY 41MM 42511000510 PSN ASF CR 10MM PLY L 3-1 42511000410 PSN ASF CR 10MM PLY L 3-9 42511000610 PSN ASF CR 10MM PLY L 7-1 42521000510 PSN ASF CR 10MM PLY R 3-1 42521000410 PSN ASF CR 10MM PLY R 3-9 42521000610 PSN ASF CR 10MM PLY R 7-1 42511000511 PSN ASF CR 11MM PLY L 3-1 42511000411 PSN ASF CR 11MM PLY L 3-9 42511000611 PSN ASF CR 11MM PLY L 7-1 42521000511 PSN ASF CR 11MM PLY R 3-1 42521000411 PSN ASF CR 11MM PLY R 3-9 42521000611 PSN ASF CR 11MM PLY R 7-1 42511000512 PSN ASF CR 12MM PLY L 3-1 42511000412 PSN ASF CR 12MM PLY L 3-9 42511000612 PSN ASF CR 12MM PLY L 7-1 42521000512 PSN ASF CR 12MM PLY R 3-1 42521000412 PSN ASF CR 12MM PLY R 3-9 42521000612 PSN ASF CR 12MM PLY R 7-1 42511000513 PSN ASF CR 13MM PLY L 3-1 42511000413 PSN ASF CR 13MM PLY L 3-9 42511000613 PSN ASF CR 13MM PLY L 7-1 42521000513 PSN ASF CR 13MM PLY R 3-1 42521000413 PSN ASF CR 13MM PLY R 3-9 42521000613 PSN ASF CR 13MM PLY R 7-1 42511000514 PSN ASF CR 14MM PLY L 3-1 42511000414 PSN ASF CR 14MM PLY L 3-9 42511000614 PSN ASF CR 14MM PLY L 7-1 42521000514 PSN ASF CR 14MM PLY R 3-1 42521000414 PSN ASF CR 14MM PLY R 3-9 42521000614 PSN ASF CR 14MM PLY R 7-1 42511000516 PSN ASF CR 16MM PLY L 3-1 42511000416 PSN ASF CR 16MM PLY L 3-9 42511000616 PSN ASF CR 16MM PLY L 7-1 42521000516 PSN ASF CR 16MM PLY R 3-1 42521000416 PSN ASF CR 16MM PLY R 3-9 42521000616 PSN ASF CR 16MM PLY R 7-1 42511000518 PSN ASF CR 18MM PLY L 3-1 42511000418 PSN ASF CR 18MM PLY L 3-9 42511000618 PSN ASF CR 18MM PLY L 7-1 42521000518 PSN ASF CR 18MM PLY R 3-1 42521000418 PSN ASF CR 18MM PLY R 3-9 42521000618 PSN ASF CR 18MM PLY R 7-1 42511400810 PSN ASF PS 10MM PLY L 10- 42511401010 PSN ASF PS 10MM PLY L 10- 42511400410 PSN ASF PS 10MM PLY L 3-5 42511400610 PSN ASF PS 10MM PLY L 3-5 42511400510 PSN ASF PS 10MM PLY L 6-9 42511400710 PSN ASF PS 10MM PLY L 6-9 42511400910 PSN ASF PS 10MM PLY L 6-9 42521400810 PSN ASF PS 10MM PLY R 10- 42521401010 PSN ASF PS 10MM PLY R 10- 42521400410 PSN ASF PS 10MM PLY R 3-5 42521400610 PSN ASF PS 10MM PLY R 3-5 42521400510 PSN ASF PS 10MM PLY R 6-9 42521400710 PSN ASF PS 10MM PLY R 6-9 42521400910 PSN ASF PS 10MM PLY R 6-9 42511400811 PSN ASF PS 11MM PLY L 10- 42511401011 PSN ASF PS 11MM PLY L 10- 42511400411 PSN ASF PS 11MM PLY L 3-5 42511400611 PSN ASF PS 11MM PLY L 3-5 42511400511 PSN ASF PS 11MM PLY L 6-9 42511400711 PSN ASF PS 11MM PLY L 6-9 42511400911 PSN ASF PS 11MM PLY L 6-9 42521400811 PSN ASF PS 11MM PLY R 10- 42521401011 PSN ASF PS 11MM PLY R 10- 42521400411 PSN ASF PS 11MM PLY R 3-5 42521400611 PSN ASF PS 11MM PLY R 3-5 42521400511 PSN ASF PS 11MM PLY R 6-9 42521400711 PSN ASF PS 11MM PLY R 6-9 42521400911 PSN ASF PS 11MM PLY R 6-9 42511400812 PSN ASF PS 12MM PLY L 10- 42511401012 PSN ASF PS 12MM PLY L 10- 42511400412 PSN ASF PS 12MM PLY L 3-5 42511400612 PSN ASF PS 12MM PLY L 3-5 42511400512 PSN ASF PS 12MM PLY L 6-9 42511400712 PSN ASF PS 12MM PLY L 6-9 42511400912 PSN ASF PS 12MM PLY L 6-9 42521400812 PSN ASF PS 12MM PLY R 10- 42521401012 PSN ASF PS 12MM PLY R 10- 42521400412 PSN ASF PS 12MM PLY R 3-5 42521400612 PSN ASF PS 12MM PLY R 3-5 42521400512 PSN ASF PS 12MM PLY R 6-9 42521400712 PSN ASF PS 12MM PLY R 6-9 42521400912 PSN ASF PS 12MM PLY R 6-9 42511400813 PSN ASF PS 13MM PLY L 10- 42511401013 PSN ASF PS 13MM PLY L 10- 42511400413 PSN ASF PS 13MM PLY L 3-5 42511400613 PSN ASF PS 13MM PLY L 3-5 42511400513 PSN ASF PS 13MM PLY L 6-9 42511400713 PSN ASF PS 13MM PLY L 6-9 42511400913 PSN ASF PS 13MM PLY L 6-9 42521400813 PSN ASF PS 13MM PLY R 10- 42521401013 PSN ASF PS 13MM PLY R 10- 42521400413 PSN ASF PS 13MM PLY R 3-5 42521400613 P

Class I - Dangerous

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Jan 11, 2016 Other Medical Devices Nationwide View Details →

Product 10consists of all product under product code HWC, and same usage: Item no: 47484502601 4.5 X 26 CORT SCREW SELF Product Usage: A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Class I - Dangerous

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Jan 11, 2016 Implants & Prosthetics Nationwide View Details →

Product 65 consists of all product under product code: KTT and same usage: Item no: 119413594 VERSA-FX II KEYLESS SHORT 119413595 VERSA-FX II KEYLESS SHORT 119413596 VERSA-FX II KEYLESS SHORT 119413004 VERSA-FX II KEYLESS TUBE 119413005 VERSA-FX II KEYLESS TUBE 119413006 VERSA-FX II KEYLESS TUBE 119413008 VERSA-FX II KEYLESS TUBE 119413504 VERSA-FX II KEYLESS TUBE 119413505 VERSA-FX II KEYLESS TUBE 119413506 VERSA-FX II KEYLESS TUBE 119413508 VERSA-FX II KEYLESS TUBE 119414004 VERSA-FX II KEYLESS TUBE 119414005 VERSA-FX II KEYLESS TUBE 119414006 VERSA-FX II KEYLESS TUBE 119414008 VERSA-FX II KEYLESS TUBE 119414504 VERSA-FX II KEYLESS TUBE 119414506 VERSA-FX II KEYLESS TUBE 119414508 VERSA-FX II KEYLESS TUBE 119415004 VERSA-FX II KEYLESS TUBE 119415005 VERSA-FX II KEYLESS TUBE 119415006 VERSA-FX II KEYLESS TUBE 119415008 VERSA-FX II KEYLESS TUBE 119313094 VERSA-FX II SHORT TUBE PL 119313095 VERSA-FX II SHORT TUBE PL 119313096 VERSA-FX II SHORT TUBE PL 119313594 VERSA-FX II SHORT TUBE PL 119313595 VERSA-FX II SHORT TUBE PL 119313596 VERSA-FX II SHORT TUBE PL 119314094 VERSA-FX II SHORT TUBE PL 119314594 VERSA-FX II SHORT TUBE PL 119314595 VERSA-FX II SHORT TUBE PL 119315094 VERSA-FX II SHORT TUBE PL 119315095 VERSA-FX II SHORT TUBE PL 119313002 VERSA-FX II STD TUBE PLAT 119313003 VERSA-FX II STD TUBE PLAT 119313004 VERSA-FX II STD TUBE PLAT 119313005 VERSA-FX II STD TUBE PLAT 119313006 VERSA-FX II STD TUBE PLAT 119313008 VERSA-FX II STD TUBE PLAT 119313010 VERSA-FX II STD TUBE PLAT 119313012 VERSA-FX II STD TUBE PLAT 119313502 VERSA-FX II STD TUBE PLAT 119313503 VERSA-FX II STD TUBE PLAT 119313504 VERSA-FX II STD TUBE PLAT 119313505 VERSA-FX II STD TUBE PLAT 119313506 VERSA-FX II STD TUBE PLAT 119313508 VERSA-FX II STD TUBE PLAT 119313510 VERSA-FX II STD TUBE PLAT 119313512 VERSA-FX II STD TUBE PLAT 119314002 VERSA-FX II STD TUBE PLAT 119314003 VERSA-FX II STD TUBE PLAT 119314004 VERSA-FX II STD TUBE PLAT 119314005 VERSA-FX II STD TUBE PLAT 119314006 VERSA-FX II STD TUBE PLAT 119314502 VERSA-FX II STD TUBE PLAT 119314503 VERSA-FX II STD TUBE PLAT 119314504 VERSA-FX II STD TUBE PLAT 119314505 VERSA-FX II STD TUBE PLAT 119314506 VERSA-FX II STD TUBE PLAT 119314510 VERSA-FX II STD TUBE PLAT 119314512 VERSA-FX II STD TUBE PLAT 119315003 VERSA-FX II STD TUBE PLAT 119315004 VERSA-FX II STD TUBE PLAT 119315005 VERSA-FX II STD TUBE PLAT 119315006 VERSA-FX II STD TUBE PLAT 119315012 VERSA-FX II STD TUBE PLAT 119315014 VERSA-FX II STD TUBE PLAT 119315018 VERSA-FX II STD TUBE PLAT 119309008 VERSA-FX II SUPRACONDYLR 119309010 VERSA-FX II SUPRACONDYLR 119309012 VERSA-FX II SUPRACONDYLR 119309014 VERSA-FX II SUPRACONDYLR 119309506 VERSA-FX II SUPRACONDYLR 119309508 VERSA-FX II SUPRACONDYLR 119309510 VERSA-FX II SUPRACONDYLR 119309512 VERSA-FX II SUPRACONDYLR 119309514 VERSA-FX II SUPRACONDYLR 119309516 VERSA-FX II SUPRACONDYLR 119309522 VERSA-FX II SUPRACONDYLR Usage: Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Class I - Dangerous

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Jan 11, 2016 Implants & Prosthetics Nationwide View Details →

Product 14 consists of all product under product code HSB , and same usage: Item no: 225600230 ASIA ONE-PIECE LAG SCREW 225600232 ASIA ONE-PIECE LAG SCREW 225600235 ASIA ONE-PIECE LAG SCREW 225600237 ASIA ONE-PIECE LAG SCREW 225600240 ASIA ONE-PIECE LAG SCREW 225600242 ASIA ONE-PIECE LAG SCREW 225600245 ASIA ONE-PIECE LAG SCREW 225600227 ASIA ONE-PIECE LAG SCREW 70MM Product Usage: An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.

Class I - Dangerous

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Jan 11, 2016 Implants & Prosthetics Nationwide View Details →

Product 19 consists of all product code: JDI and same usage: Item no: 765301101 CEM FEM ST 11X120 NOCOAT 765301201 CEM FEM ST 12X125 NOCOAT 765301301 CEM FEM ST 13X130 NOCOAT 765301401 CEM FEM ST 14X135 NOCOAT 765301501 CEM FEM ST 15X140 NOCOAT 765301601 CEM FEM ST 16X145 NOCOAT 763301300 CEM FEM ST FX 13 X 130 763301600 CEM FEM ST FX 16 X 145 For use in total or hemi hip arthroplasty

Class I - Dangerous

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Jan 11, 2016 Implants & Prosthetics Nationwide View Details →

Product 67 consists of all product under product code: JDI and same usage: Item no: 785001100 VERSYS ADVOCATE CEMENTED 785001200 VERSYS ADVOCATE CEMENTED 785001220 VERSYS ADVOCATE CEMENTED 785001300 VERSYS ADVOCATE CEMENTED 785001320 VERSYS ADVOCATE CEMENTED 785001400 VERSYS ADVOCATE CEMENTED 785001420 VERSYS ADVOCATE CEMENTED 785001500 VERSYS ADVOCATE CEMENTED 785001520 VERSYS ADVOCATE CEMENTED 785001600 VERSYS ADVOCATE CEMENTED 785001620 VERSYS ADVOCATE CEMENTED 785001700 VERSYS ADVOCATE CEMENTED 785001305 VERSYS ADVOCATE V-LIGN CE 785001325 VERSYS ADVOCATE V-LIGN CE 785001405 VERSYS ADVOCATE V-LIGN CE 785001505 VERSYS ADVOCATE V-LIGN CE 785001525 VERSYS ADVOCATE V-LIGN CE For use in total or hemi hip arthroplasty

Class I - Dangerous

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Jan 11, 2016 Implants & Prosthetics Nationwide View Details →

Product 1 consists of all product under , product code: JWH and same usage: Item no: 47481500601 1.5 X 6 CORT SCREW HEX/SE Product Usage: A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Class I - Dangerous

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Jan 11, 2016 Implants & Prosthetics Nationwide View Details →

Product 37 consists of all product under product code: HSB and same usage: Item no: 225302055 INTERLOCKING IM SCREW LG 225303055 INTERLOCKING IM SCREW LG 225304055 INTERLOCKING IM SCREW LG 225304555 INTERLOCKING IM SCREW LG 225305055 INTERLOCKING IM SCREW LG 225305555 INTERLOCKING IM SCREW LG 225306055 INTERLOCKING IM SCREW LG 225306555 INTERLOCKING IM SCREW LG 225307055 INTERLOCKING IM SCREW LG 225307555 INTERLOCKING IM SCREW LG 225308055 INTERLOCKING IM SCREW LG 225308555 INTERLOCKING IM SCREW LG 225309055 INTERLOCKING IM SCREW LG 225302542 INTERLOCKING IM SCREW MED 225303042 INTERLOCKING IM SCREW MED 225303542 INTERLOCKING IM SCREW MED 225304042 INTERLOCKING IM SCREW MED 225304542 INTERLOCKING IM SCREW MED 225305042 INTERLOCKING IM SCREW MED 225305542 INTERLOCKING IM SCREW MED 225306042 INTERLOCKING IM SCREW MED 225306542 INTERLOCKING IM SCREW MED 225307042 INTERLOCKING IM SCREW MED 225307542 INTERLOCKING IM SCREW MED 225308042 INTERLOCKING IM SCREW MED 225308542 INTERLOCKING IM SCREW MED 225302037 INTERLOCKING IM SCREW SML 225302537 INTERLOCKING IM SCREW SML 225303037 INTERLOCKING IM SCREW SML 225303537 INTERLOCKING IM SCREW SML 225304037 INTERLOCKING IM SCREW SML 225304537 INTERLOCKING IM SCREW SML 225305037 INTERLOCKING IM SCREW SML 225305537 INTERLOCKING IM SCREW SML 225306037 INTERLOCKING IM SCREW SML 225306537 INTERLOCKING IM SCREW SML 225308537 INTERLOCKING IM SCREW SML Product Usage: An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.

Class I - Dangerous

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Jan 11, 2016 Implants & Prosthetics Nationwide View Details →

Product 27 consists of all product under product code: HSB and same usage: Item no: 234703104 DISTAL MEDIAL FEMORAL CON 234703206 DISTAL MEDIAL FEMORAL CON 234703208 DISTAL MEDIAL FEMORAL CON 234800504 DISTAL POSTERIOR/LATERAL 234800506 DISTAL POSTERIOR/LATERAL 234800508 DISTAL POSTERIOR/LATERAL 234800510 DISTAL POSTERIOR/LATERAL 234800604 DISTAL POSTERIOR/LATERAL 234800606 DISTAL POSTERIOR/LATERAL 234800608 DISTAL POSTERIOR/LATERAL 234800610 DISTAL POSTERIOR/LATERAL 234800614 DISTAL POSTERIOR/LATERAL Product Usage: An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.

Class I - Dangerous

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Jan 11, 2016 Implants & Prosthetics Nationwide View Details →

Product 7 consists of all products under product code HWC, and same usage: Item no: 47234801435 3.5MM CORT SCR X 14MM 47234801635 3.5MM CORT SCR X 16MM 47234806535 3.5MM CORT SCR X 65MM 47234807035 3.5MM CORT SCR X 70MM 47234807535 3.5MM CORT SCR X 75MM 47234808035 3.5MM CORT SCR X 80MM 47234808535 3.5MM CORT SCR X 85MM 47234809035 3.5MM CORT SCR X 90MM Product Usage: A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Class I - Dangerous

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Jan 11, 2016 Implants & Prosthetics Nationwide View Details →

Product 8 consists of all products under product code HWC, and same usage: Item no: 47483501201 3.5MM CORT. SCREW 12MM LN 47483501401 3.5MM CORT. SCREW 14MM LN 47483501601 3.5MM CORT. SCREW 16MM LN 47483501801 3.5MM CORT. SCREW 18MM LN 47483503601 3.5MM CORT. SCREW 36MM LN 47483507501 3.5MM CORT. SCREW 75MM LN Product Usage: A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Class I - Dangerous

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Jan 11, 2016 Implants & Prosthetics Nationwide View Details →

Product 3 consists of all products under product code JDI, and same usage: Item no:781803800 12/14 UNIPOLAR FEMORAL HE 781804000 12/14 UNIPOLAR FEMORAL HE 781804100 12/14 UNIPOLAR FEMORAL HE 781804200 12/14 UNIPOLAR FEMORAL HE 781804300 12/14 UNIPOLAR FEMORAL HE 781804400 12/14 UNIPOLAR FEMORAL HE 781804500 12/14 UNIPOLAR FEMORAL HE 781804600 12/14 UNIPOLAR FEMORAL HE 781804700 12/14 UNIPOLAR FEMORAL HE 781804800 12/14 UNIPOLAR FEMORAL HE 781804900 12/14 UNIPOLAR FEMORAL HE 781805000 12/14 UNIPOLAR FEMORAL HE 781805100 12/14 UNIPOLAR FEMORAL HE 781805200 12/14 UNIPOLAR FEMORAL HE 781805300 12/14 UNIPOLAR FEMORAL HE 781805400 12/14 UNIPOLAR FEMORAL HE 781805500 12/14 UNIPOLAR FEMORAL HE 781806300 12/14 UNIPOLAR FEMORAL HE 781809900 12/14 UNIPOLAR FEMORAL HE 781809901 12/14 UNIPOLAR FEMORAL HE 781809902 12/14 UNIPOLAR FEMORAL HE Product For use in total or hemi hip arthroplasty

Class I - Dangerous

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Jan 11, 2016 Implants & Prosthetics Nationwide View Details →

Product 15 consists of all product code JDI , and same usage: Item no: 805002802 ASTEL FEM HEAD +0X28MM DI 805002805 ASTEL FEM HEAD +10.5X28MM 805002803 ASTEL FEM HEAD +3.5X28MM 805002804 ASTEL FEM HEAD +7X28MM DI 805002801 ASTEL FEM HEAD -3.5X28MM Usage: For use in total or hemi hip arthroplasty

Class I - Dangerous

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Jan 11, 2016 Implants & Prosthetics Nationwide View Details →

Product 56 consists of all product under product code: HWC and same usage: Item no: 47234702032 PERI SCR 3.5MM X 32MM STE 47234702018 PERI SCR. 3.5MM X 18MM ST 47234702020 PERI SCR. 3.5MM X 20MM ST 47234702022 PERI SCR. 3.5MM X 22MM ST 47234702026 PERI SCR. 3.5MM X 26MM ST 47234702030 PERI SCR. 3.5MM X 30MM ST 47234702034 PERI SCR. 3.5MM X 34MM ST 47234702036 PERI SCR. 3.5MM X 36MM ST 47234702042 PERI SCR. 3.5MM X 42MM ST 47234702046 PERI SCR. 3.5MM X 46MM ST 47234702050 PERI SCR. 3.5MM X 50MM ST 47234702080 PERI SCR. 3.5MM X 80MM ST 47234702085 PERI SCR. 3.5MM X 85MM ST 47234702155 PERI SCR. 4.0MM X 55MM 47234702160 PERI SCR. 4.0MM X 60MM 47234702210 PERI SCR. 4.0MMX10MM FULL 47234702212 PERI SCR. 4.0MMX12MM FULL 47234702214 PERI SCR. 4.0MMX14MM FULL 47234702216 PERI SCR. 4.0MMX16MM FULL 47234702260 PERI SCR. 4.0MMX60MM FULL 47234702336 PERI SCR. 4.5MM X 36MM 47234702338 PERI SCR. 4.5MM X 38MM 47234712440 PERI SCR. 6.5MM X 140MM 47234702670 PERI SCR. 6.5MM X 70MM 47234702122 PERI. SCR 4.0MM X22MM 47234702124 PERI. SCR 4.0MM X24MM 47234702126 PERI. SCR 4.0MM X26MM 47234702128 PERI. SCR 4.0MM X28MM Usage: A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Class I - Dangerous

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Jan 11, 2016 Implants & Prosthetics Nationwide View Details →

Product 42 consists of all product under product code: HSB and same usage: Item no: 225224010 M/DN FEM IM NAIL 10MM DIA 225228010 M/DN FEM IM NAIL 10MM DIA 225230010 M/DN FEM IM NAIL 10MM DIA 225232010 M/DN FEM IM NAIL 10MM DIA 225234010 M/DN FEM IM NAIL 10MM DIA 225236010 M/DN FEM IM NAIL 10MM DIA 225238010 M/DN FEM IM NAIL 10MM DIA 225240010 M/DN FEM IM NAIL 10MM DIA 225242010 M/DN FEM IM NAIL 10MM DIA 225244010 M/DN FEM IM NAIL 10MM DIA 225246010 M/DN FEM IM NAIL 10MM DIA 225228011 M/DN FEM IM NAIL 11MM DIA 225230011 M/DN FEM IM NAIL 11MM DIA 225232011 M/DN FEM IM NAIL 11MM DIA 225234011 M/DN FEM IM NAIL 11MM DIA 225236011 M/DN FEM IM NAIL 11MM DIA 225238011 M/DN FEM IM NAIL 11MM DIA 225240011 M/DN FEM IM NAIL 11MM DIA 225242011 M/DN FEM IM NAIL 11MM DIA 225244011 M/DN FEM IM NAIL 11MM DIA 225246011 M/DN FEM IM NAIL 11MM DIA 225224012 M/DN FEM IM NAIL 12MM DIA 225232012 M/DN FEM IM NAIL 12MM DIA 225234012 M/DN FEM IM NAIL 12MM DIA 225236012 M/DN FEM IM NAIL 12MM DIA 225238012 M/DN FEM IM NAIL 12MM DIA 225240012 M/DN FEM IM NAIL 12MM DIA 225242012 M/DN FEM IM NAIL 12MM DIA 225244012 M/DN FEM IM NAIL 12MM DIA 225246012 M/DN FEM IM NAIL 12MM DIA 225228013 M/DN FEM IM NAIL 13MM DIA 225230013 M/DN FEM IM NAIL 13MM DIA 225232013 M/DN FEM IM NAIL 13MM DIA 225234013 M/DN FEM IM NAIL 13MM DIA 225236013 M/DN FEM IM NAIL 13MM DIA 225238013 M/DN FEM IM NAIL 13MM DIA 225240013 M/DN FEM IM NAIL 13MM DIA 225242013 M/DN FEM IM NAIL 13MM DIA 225244013 M/DN FEM IM NAIL 13MM DIA 225246013 M/DN FEM IM NAIL 13MM DIA 225236014 M/DN FEM IM NAIL 14MM DIA 225238014 M/DN FEM IM NAIL 14MM DIA 225240014 M/DN FEM IM NAIL 14MM DIA 225242014 M/DN FEM IM NAIL 14MM DIA 225244014 M/DN FEM IM NAIL 14MM DIA 225246014 M/DN FEM IM NAIL 14MM DIA 225234015 M/DN FEM IM NAIL 15MM DIA 225240015 M/DN FEM IM NAIL 15MM DIA 225242015 M/DN FEM IM NAIL 15MM DIA 225244015 M/DN FEM IM NAIL 15MM DIA 225242016 M/DN FEM IM NAIL 16MM DIA 225230008 M/DN FEM IM NAIL 8MM DIA 225232008 M/DN FEM IM NAIL 8MM DIA 225234008 M/DN FEM IM NAIL 8MM DIA 225238008 M/DN FEM IM NAIL 8MM DIA 225228009 M/DN FEM IM NAIL 9MM DIA 225230009 M/DN FEM IM NAIL 9MM DIA 225232009 M/DN FEM IM NAIL 9MM DIA 225234009 M/DN FEM IM NAIL 9MM DIA 225236009 M/DN FEM IM NAIL 9MM DIA 225238009 M/DN FEM IM NAIL 9MM DIA 225240009 M/DN FEM IM NAIL 9MM DIA 225242009 M/DN FEM IM NAIL 9MM DIA 225244009 M/DN FEM IM NAIL 9MM DIA 225418010 M/DN HUMERAL I/M NAIL 10M 225419510 M/DN HUMERAL I/M NAIL 10M 225421010 M/DN HUMERAL I/M NAIL 10M 225422510 M/DN HUMERAL I/M NAIL 10M 225424010 M/DN HUMERAL I/M NAIL 10M 225425510 M/DN HUMERAL I/M NAIL 10M 225427010 M/DN HUMERAL I/M NAIL 10M 225428510 M/DN HUMERAL I/M NAIL 10M 225430010 M/DN HUMERAL I/M NAIL 10M 225419511 M/DN HUMERAL I/M NAIL 11M 225421011 M/DN HUMERAL I/M NAIL 11M 225422511 M/DN HUMERAL I/M NAIL 11M 225424011 M/DN HUMERAL I/M NAIL 11M 225425511 M/DN HUMERAL I/M NAIL 11M 225427011 M/DN HUMERAL I/M NAIL 11M 225421012 M/DN HUMERAL I/M NAIL 12M 225422512 M/DN HUMERAL I/M NAIL 12M 225424012 M/DN HUMERAL I/M NAIL 12M 225425512 M/DN HUMERAL I/M NAIL 12M 225427012 M/DN HUMERAL I/M NAIL 12M 225428512 M/DN HUMERAL I/M NAIL 12M 225430012 M/DN HUMERAL I/M NAIL 12M 225418013 M/DN HUMERAL I/M NAIL 13M 225424013 M/DN HUMERAL I/M NAIL 13M 225427013 M/DN HUMERAL I/M NAIL 13M 225418006 M/DN HUMERAL I/M NAIL 6MM 225419506 M/DN HUMERAL I/M NAIL 6MM 225421006 M/DN HUMERAL I/M NAIL 6MM 225424006 M/DN HUMERAL I/M NAIL 6MM 225427006 M/DN HUMERAL I/M NAIL 6MM 225428506 M/DN HUMERAL I/M NAIL 6MM 225430006 M/DN HUMERAL I/M NAIL 6MM 225418007 M/DN HUMERAL I/M NAIL 7MM 225419507 M/DN HUMERAL I/M NAIL 7MM 225421007 M/DN HUMERAL I/M NAIL 7MM 225422507 M/DN HUMERAL I/M NAIL 7MM 225424007 M/DN HUMERAL I/M NAIL 7MM 225425507 M/DN HUMERAL I/M NAIL 7MM 225427007 M/DN HUMERAL I/M NAIL 7MM 225428507 M/DN HUMERAL I/M NAIL 7MM 225430007 M/DN HUMERAL I/M NAIL 7MM 225418008 M/DN HUMERAL I/M NAIL 8MM 225

Class I - Dangerous

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Jan 11, 2016 Other Medical Devices Nationwide View Details →

Product 43 consists of all product under product code: HSB and same usage: Item no: 224001016 M/DN R-F IM NAIL 10MM DIA 224001018 M/DN R-F IM NAIL 10MM DIA 224001020 M/DN R-F IM NAIL 10MM DIA 224001022 M/DN R-F IM NAIL 10MM DIA 224001024 M/DN R-F IM NAIL 10MM DIA 224001026 M/DN R-F IM NAIL 10MM DIA 224001028 M/DN R-F IM NAIL 10MM DIA 224001030 M/DN R-F IM NAIL 10MM DIA 224001032 M/DN R-F IM NAIL 10MM DIA 224001034 M/DN R-F IM NAIL 10MM DIA 224001036 M/DN R-F IM NAIL 10MM DIA 224001038 M/DN R-F IM NAIL 10MM DIA 224001040 M/DN R-F IM NAIL 10MM DIA 224001042 M/DN R-F IM NAIL 10MM DIA 224001114 M/DN R-F IM NAIL 11MM DIA 224001116 M/DN R-F IM NAIL 11MM DIA 224001118 M/DN R-F IM NAIL 11MM DIA 224001120 M/DN R-F IM NAIL 11MM DIA 224001122 M/DN R-F IM NAIL 11MM DIA 224001124 M/DN R-F IM NAIL 11MM DIA 224001126 M/DN R-F IM NAIL 11MM DIA 224001128 M/DN R-F IM NAIL 11MM DIA 224001130 M/DN R-F IM NAIL 11MM DIA 224001132 M/DN R-F IM NAIL 11MM DIA 224001134 M/DN R-F IM NAIL 11MM DIA 224001136 M/DN R-F IM NAIL 11MM DIA 224001138 M/DN R-F IM NAIL 11MM DIA 224001140 M/DN R-F IM NAIL 11MM DIA 224001142 M/DN R-F IM NAIL 11MM DIA 224001144 M/DN R-F IM NAIL 11MM DIA 224001146 M/DN R-F IM NAIL 11MM DIA 224001218 M/DN R-F IM NAIL 12MM DIA 224001220 M/DN R-F IM NAIL 12MM DIA 224001224 M/DN R-F IM NAIL 12MM DIA 224001226 M/DN R-F IM NAIL 12MM DIA 224001228 M/DN R-F IM NAIL 12MM DIA 224001230 M/DN R-F IM NAIL 12MM DIA 224001232 M/DN R-F IM NAIL 12MM DIA 224001234 M/DN R-F IM NAIL 12MM DIA 224001236 M/DN R-F IM NAIL 12MM DIA 224001238 M/DN R-F IM NAIL 12MM DIA 224001240 M/DN R-F IM NAIL 12MM DIA 224001242 M/DN R-F IM NAIL 12MM DIA 224001244 M/DN R-F IM NAIL 12MM DIA 224001248 M/DN R-F IM NAIL 12MM DIA 224001318 M/DN R-F IM NAIL 13MM DIA 224001324 M/DN R-F IM NAIL 13MM DIA 224001326 M/DN R-F IM NAIL 13MM DIA 224001328 M/DN R-F IM NAIL 13MM DIA 224001330 M/DN R-F IM NAIL 13MM DIA 224001332 M/DN R-F IM NAIL 13MM DIA 224001334 M/DN R-F IM NAIL 13MM DIA 224001336 M/DN R-F IM NAIL 13MM DIA 224001338 M/DN R-F IM NAIL 13MM DIA 224001340 M/DN R-F IM NAIL 13MM DIA 224001344 M/DN R-F IM NAIL 13MM DIA 224001346 M/DN R-F IM NAIL 13MM DIA 224001348 M/DN R-F IM NAIL 13MM DIA 224001422 M/DN R-F IM NAIL 14MM DIA 224001436 M/DN R-F IM NAIL 14MM DIA 224001438 M/DN R-F IM NAIL 14MM DIA 224001440 M/DN R-F IM NAIL 14MM DIA 224001442 M/DN R-F IM NAIL 14MM DIA 224001444 M/DN R-F IM NAIL 14MM DIA 224001446 M/DN R-F IM NAIL 14MM DIA 224000922 M/DN R-F IM NAIL 9MM DIA 224000926 M/DN R-F IM NAIL 9MM DIA 224000928 M/DN R-F IM NAIL 9MM DIA 224000930 M/DN R-F IM NAIL 9MM DIA 224000932 M/DN R-F IM NAIL 9MM DIA 224000934 M/DN R-F IM NAIL 9MM DIA 224000936 M/DN R-F IM NAIL 9MM DIA 224000942 M/DN R-F IM NAIL 9MM DIA 224000946 M/DN R-F IM NAIL 9MM DIA 225320010 M/DN TIBIAL I/M NAIL 10MM 225326010 M/DN TIBIAL I/M NAIL 10MM 225328010 M/DN TIBIAL I/M NAIL 10MM 225330010 M/DN TIBIAL I/M NAIL 10MM 225332010 M/DN TIBIAL I/M NAIL 10MM 225334010 M/DN TIBIAL I/M NAIL 10MM 225336010 M/DN TIBIAL I/M NAIL 10MM 225338010 M/DN TIBIAL I/M NAIL 10MM 225344010 M/DN TIBIAL I/M NAIL 10MM 225320011 M/DN TIBIAL I/M NAIL 11MM 225322011 M/DN TIBIAL I/M NAIL 11MM 225324011 M/DN TIBIAL I/M NAIL 11MM 225326011 M/DN TIBIAL I/M NAIL 11MM 225328011 M/DN TIBIAL I/M NAIL 11MM 225330011 M/DN TIBIAL I/M NAIL 11MM 225332011 M/DN TIBIAL I/M NAIL 11MM 225334011 M/DN TIBIAL I/M NAIL 11MM 225336011 M/DN TIBIAL I/M NAIL 11MM 225338011 M/DN TIBIAL I/M NAIL 11MM 225340011 M/DN TIBIAL I/M NAIL 11MM 225342011 M/DN TIBIAL I/M NAIL 11MM 225344011 M/DN TIBIAL I/M NAIL 11MM 225346011 M/DN TIBIAL I/M NAIL 11MM 225328012 M/DN TIBIAL I/M NAIL 12MM 225330012 M/DN TIBIAL I/M NAIL 12MM 225332012 M/DN TIBIAL I/M NAIL 12MM 225334012 M/DN TIBIAL I/M NAIL 12MM 225336012 M/DN TIBIAL I/M NAIL 12MM 225338012 M/DN TIBIAL I/M NAIL 12MM 225340012 M/DN TIBIAL I/M NAIL 12MM 225346012 M/DN TIBIAL I/M NAIL 12MM 225324013 M/DN TIBIAL I/M NAIL 13MM

Class I - Dangerous

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Jan 11, 2016 Other Medical Devices Nationwide View Details →

Product 4 consists of all products under product code HWC, and same usage: Item no: 47482002603 2.0 X 26 CORT SCREW CRUCI 47482002803 2.0 X 28 CORT SCREW CRUCI 47482003203 2.0 X 32 CORT SCREW CRUCI 47482003403 2.0 X 34 CORT SCREW CRUCI 47482003603 2.0 X 36 CORT SCREW CRUCI 47482003803 2.0 X 38 CORT SCREW CRUCI 47482004003 2.0 X 40 CORT SCREW CRUCI 47482004203 2.0 X 42 CORT SCREW CRUCI 47482004403 2.0 X 44 CORT SCREW CRUCI 47482004603 2.0 X 46 CORT SCREW CRUCI 47482004803 2.0 X 48 CORT SCREW CRUCI 47482005003 2.0 X 50 CORT SCREW CRUCI 47482702000 2.7 X 20 CORT SCREW HEX Product Usage: A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Class I - Dangerous

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Jan 11, 2016 Implants & Prosthetics Nationwide View Details →

Product 16 consists of all product under poduct code: KWY and same usage: Item no: 500103822 BIPOLAR LINER 38MM OD X 2 500103922 BIPOLAR LINER 39MM OD X 2 500104022 BIPOLAR LINER 40/41MM OD 500104026 BIPOLAR LINER 40MM OD X 2 500104222 BIPOLAR LINER 42/43 OD X 500104226 BIPOLAR LINER 42MM OD X 2 500104428 BIPOLAR LINER 44/45/46MM 500104422 BIPOLAR LINER 44MM OD X 2 500104426 BIPOLAR LINER 44MM OD X 2 500104728 BIPOLAR LINER 47/48/49MM 500104722 BIPOLAR LINER 47MM OD X 2 500104726 BIPOLAR LINER 47MM OD X 2 500104732 BIPOLAR LINER 47MM OD X 3 500105028 BIPOLAR LINER 50/51/52MM 500105022 BIPOLAR LINER 50MM OD X 2 500105026 BIPOLAR LINER 50MM OD X 2 500105328 BIPOLAR LINER 53/54/55MM 500105322 BIPOLAR LINER 53MM OD X 2 500105326 BIPOLAR LINER 53MM OD X 2 500105728 BIPOLAR LINER 57/58MM OD 500105722 BIPOLAR LINER 57MM OD X 2 500106028 BIPOLAR LINER 60/62MM OD 500106828 BIPOLAR LINER 68/70MM OD 500106832 BIPOLAR LINER 68MM OD X 3 500107228 BIPOLAR LINER 72MM OD X 2 500103800 BIPOLAR SHELL 38MM OD 500103900 BIPOLAR SHELL 39MM OD 500104000 BIPOLAR SHELL 40MM OD 500104100 BIPOLAR SHELL 41MM OD 500104200 BIPOLAR SHELL 42MM OD 500104300 BIPOLAR SHELL 43MM OD 500104400 BIPOLAR SHELL 44MM OD 500104500 BIPOLAR SHELL 45MM OD 500104600 BIPOLAR SHELL 46MM OD 500104700 BIPOLAR SHELL 47MM OD 500104800 BIPOLAR SHELL 48MM OD 500104900 BIPOLAR SHELL 49MM OD 500105000 BIPOLAR SHELL 50MM OD 500105100 BIPOLAR SHELL 51MM OD 500105200 BIPOLAR SHELL 52MM OD 500105300 BIPOLAR SHELL 53MM OD 500105400 BIPOLAR SHELL 54MM OD 500105500 BIPOLAR SHELL 55MM OD 500105700 BIPOLAR SHELL 57MM OD 500105800 BIPOLAR SHELL 58MM OD 500106000 BIPOLAR SHELL 60MM OD 500106200 BIPOLAR SHELL 62MM OD 500107000 BIPOLAR SHELL 70MM OD Product Usage: For use in total or hemi hip arthroplasty

Class I - Dangerous

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

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Product 46 consists of all product under product code: HWC and same usage: Item no: 114204012 MINI MAGNA-FX CANN SCREW 114204016 MINI MAGNA-FX CANN SCREW 114204020 MINI MAGNA-FX CANN SCREW 114204024 MINI MAGNA-FX CANN SCREW 114204028 MINI MAGNA-FX CANN SCREW 114204032 MINI MAGNA-FX CANN SCREW 114204036 MINI MAGNA-FX CANN SCREW 114204040 MINI MAGNA-FX CANN SCREW 114204044 MINI MAGNA-FX CANN SCREW 114204048 MINI MAGNA-FX CANN SCREW 114204055 MINI MAGNA-FX CANN SCREW 114204065 MINI MAGNA-FX CANN SCREW 114204124 MINI MAGNA-FX CANN SCREW 114204126 MINI MAGNA-FX CANN SCREW 114204128 MINI MAGNA-FX CANN SCREW 114204130 MINI MAGNA-FX CANN SCREW 114204132 MINI MAGNA-FX CANN SCREW 114204134 MINI MAGNA-FX CANN SCREW 114204136 MINI MAGNA-FX CANN SCREW 114204138 MINI MAGNA-FX CANN SCREW 114204140 MINI MAGNA-FX CANN SCREW 114204142 MINI MAGNA-FX CANN SCREW 114204144 MINI MAGNA-FX CANN SCREW 114204146 MINI MAGNA-FX CANN SCREW 114204148 MINI MAGNA-FX CANN SCREW 114204150 MINI MAGNA-FX CANN SCREW 114204155 MINI MAGNA-FX CANN SCREW 114204160 MINI MAGNA-FX CANN SCREW 114204165 MINI MAGNA-FX CANN SCREW 114204170 MINI MAGNA-FX CANN SCREW 114205012 MINI MAGNA-FX CANN SCREW 114205016 MINI MAGNA-FX CANN SCREW 114205020 MINI MAGNA-FX CANN SCREW 114205024 MINI MAGNA-FX CANN SCREW 114205028 MINI MAGNA-FX CANN SCREW 114205032 MINI MAGNA-FX CANN SCREW 114205036 MINI MAGNA-FX CANN SCREW 114205040 MINI MAGNA-FX CANN SCREW 114205044 MINI MAGNA-FX CANN SCREW 114205048 MINI MAGNA-FX CANN SCREW 114205055 MINI MAGNA-FX CANN SCREW 114205065 MINI MAGNA-FX CANN SCREW 114205124 MINI MAGNA-FX CANN SCREW 114205126 MINI MAGNA-FX CANN SCREW 114205128 MINI MAGNA-FX CANN SCREW 114205130 MINI MAGNA-FX CANN SCREW 114205132 MINI MAGNA-FX CANN SCREW 114205134 MINI MAGNA-FX CANN SCREW 114205136 MINI MAGNA-FX CANN SCREW 114205138 MINI MAGNA-FX CANN SCREW 114205140 MINI MAGNA-FX CANN SCREW 114205142 MINI MAGNA-FX CANN SCREW 114205144 MINI MAGNA-FX CANN SCREW 114205146 MINI MAGNA-FX CANN SCREW 114205148 MINI MAGNA-FX CANN SCREW 114205150 MINI MAGNA-FX CANN SCREW 114205155 MINI MAGNA-FX CANN SCREW 114205160 MINI MAGNA-FX CANN SCREW 114205165 MINI MAGNA-FX CANN SCREW 114205170 MINI MAGNA-FX CANN SCREW Product Usage: A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Class I - Dangerous

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

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Product 69 consists of all product under product code: JDI and same usage: Item no: 785301701 VERSYS CEMENTED FEM STEM 785301521 VERSYS CEMENTED FEM STEM 15X140MM X-OFF 785301601 VERSYS CEMENTED FEM STEM 16X145MM For use in total or hemi hip arthroplasty

Class I - Dangerous

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

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Product 30 consists of all product under product code: KTT and same usage: Item no: 118100527 FREE-LOCK LAG SCREW, 12.7 118100535 FREE-LOCK LAG SCREW, 12.7 118100540 FREE-LOCK LAG SCREW, 12.7 118100542 FREE-LOCK LAG SCREW, 12.7 118101022 FREE-LOCK LAG SCREW, 12.7 118101025 FREE-LOCK LAG SCREW, 12.7 118101027 FREE-LOCK LAG SCREW, 12.7 118101030 FREE-LOCK LAG SCREW, 12.7 118101032 FREE-LOCK LAG SCREW, 12.7 118101035 FREE-LOCK LAG SCREW, 12.7 118101037 FREE-LOCK LAG SCREW, 12.7 118101040 FREE-LOCK LAG SCREW, 12.7 118101042 FREE-LOCK LAG SCREW, 12.7 118101045 FREE-LOCK LAG SCREW, 12.7 118101047 FREE-LOCK LAG SCREW, 12.7 118101052 FREE-LOCK LAG SCREW, 12.7 118101055 FREE-LOCK LAG SCREW, 12.7 118101057 FREE-LOCK LAG SCREW, 12.7 118101522 FREE-LOCK LAG SCREW, 15.8 118101525 FREE-LOCK LAG SCREW, 15.8 118101527 FREE-LOCK LAG SCREW, 15.8 118101530 FREE-LOCK LAG SCREW, 15.8 118101532 FREE-LOCK LAG SCREW, 15.8 118101547 FREE-LOCK LAG SCREW, 15.8 118109010 FREE-LOCK SUPRACOND TUBE/ 118109510 FREE-LOCK SUPRACOND TUBE/ 118113005 FREE-LOCK TUBE & SCP PLAT 118113006 FREE-LOCK TUBE & SCP PLAT 118113010 FREE-LOCK TUBE & SCP PLAT 118113504 FREE-LOCK TUBE & SCP PLAT 118113505 FREE-LOCK TUBE & SCP PLAT 118113506 FREE-LOCK TUBE & SCP PLAT 118113508 FREE-LOCK TUBE & SCP PLAT 118113510 FREE-LOCK TUBE & SCP PLAT 118113594 FREE-LOCK TUBE & SCP PLAT 118114005 FREE-LOCK TUBE & SCP PLAT 118114006 FREE-LOCK TUBE & SCP PLAT 118114008 FREE-LOCK TUBE & SCP PLAT 118114010 FREE-LOCK TUBE & SCP PLAT 118114012 FREE-LOCK TUBE & SCP PLAT 118114004 FREE-LOCK TUBE & SCP PLAT 118114008 FREE-LOCK TUBE & SCP PLAT 118114010 FREE-LOCK TUBE & SCP PLAT 118114012 FREE-LOCK TUBE & SCP PLAT 118114504 FREE-LOCK TUBE & SCP PLAT 118114505 FREE-LOCK TUBE & SCP PLAT 118114506 FREE-LOCK TUBE & SCP PLAT 118114508 FREE-LOCK TUBE & SCP PLAT 118114512 FREE-LOCK TUBE & SCP PLAT 118114594 FREE-LOCK TUBE & SCP PLAT 118114508 FREE-LOCK TUBE & SCP PLAT 118114512 FREE-LOCK TUBE & SCP PLAT 118114594 FREE-LOCK TUBE & SCP PLAT 118115004 FREE-LOCK TUBE & SCP PLAT 118115005 FREE-LOCK TUBE & SCP PLAT 118115006 FREE-LOCK TUBE & SCP PLAT 118115008 FREE-LOCK TUBE & SCP PLAT 118115094 FREE-LOCK TUBE & SCP PLAT 118113508 FREE-LOCK TUBE & SCP PLAT 118113506 FREE-LOCK TUBE & SCP PLAT 118113505 FREE-LOCK TUBE & SCP PLAT 118113504 FREE-LOCK TUBE & SCP PLAT 118113004 FREE-LOCK TUBE & SCP PLAT Product Usage: Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Class I - Dangerous

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

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Product 60 consists of all product under product code: HSB and same usage: Item no: 225207055 RECON SCREW LG 5.5MM DIA 225207555 RECON SCREW LG 5.5MM DIA 225208055 RECON SCREW LG 5.5MM DIA 225208555 RECON SCREW LG 5.5MM DIA 225209055 RECON SCREW LG 5.5MM DIA 225209555 RECON SCREW LG 5.5MM DIA 225210055 RECON SCREW LG 5.5MM DIA 225210555 RECON SCREW LG 5.5MM DIA 225211555 RECON SCREW LG 5.5MM DIA 225212055 RECON SCREW LG 5.5MM DIA 225213055 RECON SCREW LG 5.5MM DIA Usage: An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.

Class I - Dangerous

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

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Product 53 consists of all product under: product code: JWH and same usage: Item no: 597002501 NEXGEN PRECOAT PEG TIB PL 597002502 NEXGEN PRECOAT PEG TIB PL 597003501 NEXGEN PRECOAT PEG TIB PL 597003502 NEXGEN PRECOAT PEG TIB PL 597004501 NEXGEN PRECOAT PEG TIB PL 597004502 NEXGEN PRECOAT PEG TIB PL 597005501 NEXGEN PRECOAT PEG TIB PL 597005502 NEXGEN PRECOAT PEG TIB PL 597005503 NEXGEN PRECOAT PEG TIB PL 597005504 NEXGEN PRECOAT PEG TIB PL 598002701 NEXGEN PRECOAT STEMMED TI 598002702 NEXGEN PRECOAT STEMMED TI 598003701 NEXGEN PRECOAT STEMMED TI 598003702 NEXGEN PRECOAT STEMMED TI 598004701 NEXGEN PRECOAT STEMMED TI 598004702 NEXGEN PRECOAT STEMMED TI 598005701 NEXGEN PRECOAT STEMMED TI 598005702 NEXGEN PRECOAT STEMMED TI 598005703 NEXGEN PRECOAT STEMMED TI 598005704 NEXGEN PRECOAT STEMMED TI 598801510 NEXGEN SHARP FLUTED STEM 598801511 NEXGEN SHARP FLUTED STEM 598801512 NEXGEN SHARP FLUTED STEM 598801513 NEXGEN SHARP FLUTED STEM 598801514 NEXGEN SHARP FLUTED STEM 598801515 NEXGEN SHARP FLUTED STEM 598801516 NEXGEN SHARP FLUTED STEM 598801517 NEXGEN SHARP FLUTED STEM 598801518 NEXGEN SHARP FLUTED STEM 598801519 NEXGEN SHARP FLUTED STEM 598801520 NEXGEN SHARP FLUTED STEM 598801010 NEXGEN STRAIGHT STEM EXT 598801011 NEXGEN STRAIGHT STEM EXT 598801012 NEXGEN STRAIGHT STEM EXT 598801013 NEXGEN STRAIGHT STEM EXT 598801014 NEXGEN STRAIGHT STEM EXT 598801015 NEXGEN STRAIGHT STEM EXT 598801016 NEXGEN STRAIGHT STEM EXT 598801017 NEXGEN STRAIGHT STEM EXT 598801018 NEXGEN STRAIGHT STEM EXT 598801020 NEXGEN STRAIGHT STEM EXT 598801022 NEXGEN STRAIGHT STEM EXT 598801024 NEXGEN STRAIGHT STEM EXT 598801112 NEXGEN STRAIGHT STEM EXT 598801113 NEXGEN STRAIGHT STEM EXT 598801114 NEXGEN STRAIGHT STEM EXT 598801115 NEXGEN STRAIGHT STEM EXT 598801116 NEXGEN STRAIGHT STEM EXT 598801117 NEXGEN STRAIGHT STEM EXT 598801118 NEXGEN STRAIGHT STEM EXT 598801212 NEXGEN STRAIGHT STEM EXT 598801215 NEXGEN STRAIGHT STEM EXT for use in total knee arthroplasty

Class I - Dangerous

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

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Product 63 consists of all product under product code: LPH and same usage: Item no: 620004020 TRILOGY ACET SHELL 40MM O 620004220 TRILOGY ACET SHELL 42MM O 620004420 TRILOGY ACET SHELL 44MM O 620004620 TRILOGY ACET SHELL 46MM O 620004621 TRILOGY ACET SHELL 46MM O 620004820 TRILOGY ACET SHELL 48MM O 620004822 TRILOGY ACET SHELL 48MM O 620004823 TRILOGY ACET SHELL 48MM O 620005020 TRILOGY ACET SHELL 50MM O 620005021 TRILOGY ACET SHELL 50MM O 620005022 TRILOGY ACET SHELL 50MM O 620005220 TRILOGY ACET SHELL 52MM O 620005221 TRILOGY ACET SHELL 52MM O 620005222 TRILOGY ACET SHELL 52MM O 620005223 TRILOGY ACET SHELL 52MM O 620005420 TRILOGY ACET SHELL 54MM O 620005421 TRILOGY ACET SHELL 54MM O 620005422 TRILOGY ACET SHELL 54MM O 620005423 TRILOGY ACET SHELL 54MM O 620005620 TRILOGY ACET SHELL 56MM O 620005621 TRILOGY ACET SHELL 56MM O 620005622 TRILOGY ACET SHELL 56MM O 620005623 TRILOGY ACET SHELL 56MM O 620005820 TRILOGY ACET SHELL 58MM O 620005821 TRILOGY ACET SHELL 58MM O 620005822 TRILOGY ACET SHELL 58MM O 620005823 TRILOGY ACET SHELL 58MM O 620006020 TRILOGY ACET SHELL 60MM O 620006022 TRILOGY ACET SHELL 60MM O 620006023 TRILOGY ACET SHELL 60MM O 620006021 TRILOGY ACET SHELL 60MM OD SOLID 620006220 TRILOGY ACET SHELL 62MM O 620006221 TRILOGY ACET SHELL 62MM O 620006222 TRILOGY ACET SHELL 62MM O 620006420 TRILOGY ACET SHELL 64MM O 620006422 TRILOGY ACET SHELL 64MM O 620006620 TRILOGY ACET SHELL 66MM O For use in total hip arthroplasty

Class I - Dangerous

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

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Product 70 consists of all product under product code: JDI and same usage: Item no: 785701000 VERSYS HERITAGE FEM STEM 785701100 VERSYS HERITAGE FEM STEM 785701200 VERSYS HERITAGE FEM STEM 785701300 VERSYS HERITAGE FEM STEM 785701320 VERSYS HERITAGE FEM STEM 785701400 VERSYS HERITAGE FEM STEM 785701420 VERSYS HERITAGE FEM STEM 785701500 VERSYS HERITAGE FEM STEM 785701520 VERSYS HERITAGE FEM STEM 785701600 VERSYS HERITAGE FEM STEM 785701700 VERSYS HERITAGE FEM STEM For use in total or hemi hip arthroplasty

Class I - Dangerous

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

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Product 66 consists of all product under product code: JDI and same usage: Item no: 785001100 VERSYS ADVOCATE CEMENTED 785001200 VERSYS ADVOCATE CEMENTED 785001220 VERSYS ADVOCATE CEMENTED 785001300 VERSYS ADVOCATE CEMENTED 785001320 VERSYS ADVOCATE CEMENTED 785001400 VERSYS ADVOCATE CEMENTED 785001420 VERSYS ADVOCATE CEMENTED 785001500 VERSYS ADVOCATE CEMENTED 785001520 VERSYS ADVOCATE CEMENTED 785001600 VERSYS ADVOCATE CEMENTED 785001620 VERSYS ADVOCATE CEMENTED 785001700 VERSYS ADVOCATE CEMENTED 785001305 VERSYS ADVOCATE V-LIGN CE 785001325 VERSYS ADVOCATE V-LIGN CE 785001405 VERSYS ADVOCATE V-LIGN CE 785001505 VERSYS ADVOCATE V-LIGN CE 785001525 VERSYS ADVOCATE V-LIGN CE For use in total or hemi hip arthroplasty

Class I - Dangerous

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

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Product 20 consists of all prod oct under poduct code: KTT and same usage: Item no: 47116201900 COMPRESSION SCREW 1/2IN 47116202300 COMPRESSION SCREW 1-1/2IN 47116202200 COMPRESSION SCREW 1-1/4IN 47116202400 COMPRESSION SCREW 1-3/4IN 47116202100 COMPRESSION SCREW 1IN 47116202000 COMPRESSION SCREW 3/4IN Product Usage: Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Class I - Dangerous

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Jan 11, 2016 Implants & Prosthetics Nationwide View Details →

Product 22 consists of all product under product code: JDI and same usage: Item no: 811400218 CPT 12/14 COCR REVISION S 811400318 CPT 12/14 COCR REVISION S 811400420 CPT 12/14 COCR REVISION S 811400423 CPT 12/14 COCR REVISION S 811400426 CPT 12/14 COCR REVISION S 811400010 CPT 12/14 COCR SIZE 0 EXT 811400000 CPT 12/14 COCR SIZE 0 STD 811400110 CPT 12/14 COCR SIZE 1 EXT 811400100 CPT 12/14 COCR SIZE 1 STD 811400210 CPT 12/14 COCR SIZE 2 EXT 811400200 CPT 12/14 COCR SIZE 2 STD 811400230 CPT 12/14 COCR SIZE 2 XEX 811400310 CPT 12/14 COCR SIZE 3 EXT 811400300 CPT 12/14 COCR SIZE 3 STD 811400330 CPT 12/14 COCR SIZE 3 XEX 811400410 CPT 12/14 COCR SIZE 4 EXT 811400400 CPT 12/14 COCR SIZE 4 STD 811400430 CPT 12/14 COCR SIZE 4 XEX 811400510 CPT 12/14 COCR SIZE 5 EXT 811400500 CPT 12/14 COCR SIZE 5 STD 811400530 CPT 12/14 COCR SIZE 5 XEX For use in total or hemi hip arthroplasty

Class I - Dangerous

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

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Product 13 consists of all product under product code HWC , and same usage: Item no: 47486510002 6.5 X 100 CANC SCREW, 32M Product Usage: A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Class I - Dangerous

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Jan 11, 2016 Implants & Prosthetics Nationwide View Details →

Product 71 consists of all product under product code: JDI and same usage: Item no: 783401000 VERSYS PRESS FIT LD/FX ST 783401100 VERSYS PRESS FIT LD/FX SZ 783401200 VERSYS PRESS FIT LD/FX SZ 783401300 VERSYS PRESS FIT LD/FX SZ 783401400 VERSYS PRESS FIT LD/FX SZ 783401500 VERSYS PRESS FIT LD/FX SZ 783401600 VERSYS PRESS FIT LD/FX SZ For use in total or hemi hip arthroplasty

Class I - Dangerous

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Jan 11, 2016 Implants & Prosthetics Nationwide View Details →

Product 40 consists of all product under product code: HSB and same usage: Item no: 225706565 ITST ANTI-ROTATION SCREW 225707065 ITST ANTI-ROTATION SCREW 225708065 ITST ANTI-ROTATION SCREW 225708565 ITST ANTI-ROTATION SCREW 225709065 ITST ANTI-ROTATION SCREW Product Usage: An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.

Class I - Dangerous

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

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Product 47 consists of all product under product code: LPH and same usage: Item no: 611004022 MODULAR CUP 10 DEGREE LIN 611004428 MODULAR CUP 10 DEGREE LIN 611004628 MODULAR CUP 10 DEGREE LIN 611004828 MODULAR CUP 10 DEGREE LIN 611004832 MODULAR CUP 10 DEGREE LIN 611005028 MODULAR CUP 10 DEGREE LIN 611005032 MODULAR CUP 10 DEGREE LIN 611005628 MODULAR CUP 10 DEGREE LIN 611005632 MODULAR CUP 10 DEGREE LIN 611005828 MODULAR CUP 10 DEGREE LIN 611005832 MODULAR CUP 10 DEGREE LIN 611006028 MODULAR CUP 10 DEGREE LIN 611006032 MODULAR CUP 10 DEGREE LIN 611006228 MODULAR CUP 10 DEGREE LIN 611006232 MODULAR CUP 10 DEGREE LIN 611006428 MODULAR CUP 10 DEGREE LIN 611006432 MODULAR CUP 10 DEGREE LIN 611006628 MODULAR CUP 10 DEGREE LIN 611006832 MODULAR CUP 10 DEGREE LIN 611007028 MODULAR CUP 10 DEGREE LIN 612004626 MODULAR CUP 20 DEGREE LIN 612004628 MODULAR CUP 20 DEGREE LIN 612004828 MODULAR CUP 20 DEGREE LIN 612004832 MODULAR CUP 20 DEGREE LIN 612005028 MODULAR CUP 20 DEGREE LIN 612005032 MODULAR CUP 20 DEGREE LIN 612005628 MODULAR CUP 20 DEGREE LIN 612005828 MODULAR CUP 20 DEGREE LIN 612005832 MODULAR CUP 20 DEGREE LIN 612006028 MODULAR CUP 20 DEGREE LIN 612006032 MODULAR CUP 20 DEGREE LIN 610504428 MODULAR CUP NEUTRAL LINER 610504832 MODULAR CUP NEUTRAL LINER 610505028 MODULAR CUP NEUTRAL LINER 610505032 MODULAR CUP NEUTRAL LINER 610505632 MODULAR CUP NEUTRAL LINER 610505832 MODULAR CUP NEUTRAL LINER 610506032 MODULAR CUP NEUTRAL LINER 610506232 MODULAR CUP NEUTRAL LINER For use in total hip arthroplasty

Class I - Dangerous

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

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Product 49 consists of all product under product code: JWH and same usage: Item no: 597206529 NEXGEN ALL-POLY PATELLA, 597206532 NEXGEN ALL-POLY PATELLA, 597206535 NEXGEN ALL-POLY PATELLA, 597206538 NEXGEN ALL-POLY PATELLA, 597206541 NEXGEN ALL-POLY PATELLA, 598801713 NEXGEN CEMENTED STEM EXT 598801813 NEXGEN CEMENTED STEM EXT 598801913 NEXGEN CEMENTED STEM EXT 598801610 NEXGEN FLUTED STEM EXT, 1 598801611 NEXGEN FLUTED STEM EXT, 1 598801612 NEXGEN FLUTED STEM EXT, 1 598801613 NEXGEN FLUTED STEM EXT, 1 598801614 NEXGEN FLUTED STEM EXT, 1 598801615 NEXGEN FLUTED STEM EXT, 1 598801616 NEXGEN FLUTED STEM EXT, 1 598801618 NEXGEN FLUTED STEM EXT, 1 598801619 NEXGEN FLUTED STEM EXT, 1 598801620 NEXGEN FLUTED STEM EXT, 2 598801622 NEXGEN FLUTED STEM EXT, 2 598801624 NEXGEN FLUTED STEM EXT, 2 597206126 NEXGEN MICRO ALL-POLY PAT 597206129 NEXGEN MICRO ALL-POLY PAT 597206132 NEXGEN MICRO ALL-POLY PAT 597206135 NEXGEN MICRO ALL-POLY PAT for use in total knee arthroplasty

Class I - Dangerous

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Jan 11, 2016 Implants & Prosthetics Nationwide View Details →

Product 26 consists of all product under product code: JWH and same usage: Item no: 234703104 DISTAL MEDIAL FEMORAL CON 234703206 DISTAL MEDIAL FEMORAL CON 234703208 DISTAL MEDIAL FEMORAL CON 234800504 DISTAL POSTERIOR/LATERAL 234800506 DISTAL POSTERIOR/LATERAL 234800508 DISTAL POSTERIOR/LATERAL 234800510 DISTAL POSTERIOR/LATERAL 234800604 DISTAL POSTERIOR/LATERAL 234800606 DISTAL POSTERIOR/LATERAL 234800608 DISTAL POSTERIOR/LATERAL 234800610 DISTAL POSTERIOR/LATERAL 234800614 DISTAL POSTERIOR/LATERAL Product Usage: For use in total or hemi hip arthroplasty

Class I - Dangerous

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Jan 11, 2016 Implants & Prosthetics Nationwide View Details →

Product 41 consists of all product under product code: KTT and same usage: Item no: 119301042 LAG SCR 12.7D X 100MM STA 119301045 LAG SCR 12.7D X 105MM STA 119301047 LAG SCR 12.7D X 110MM STA 119301050 LAG SCR 12.7D X 115MM STA 119301052 LAG SCR 12.7D X 120MM STA 119301055 LAG SCR 12.7D X 125MM STA 119301057 LAG SCR 12.7D X 130MM STA 119301060 LAG SCR 12.7D X 135MM STA 119301062 LAG SCR 12.7D X 140MM STA 119301070 LAG SCR 12.7D X 155MM STA 119301020 LAG SCR 12.7D X 55MM STAN 119301022 LAG SCR 12.7D X 60MM STAN 119301025 LAG SCR 12.7D X 65MM STAN 119301027 LAG SCR 12.7D X 70MM STAN 119301030 LAG SCR 12.7D X 75MM STAN 119301032 LAG SCR 12.7D X 80MM STAN 119301035 LAG SCR 12.7D X 85MM STAN 119300537 LAG SCR 12.7D X 90MM SHOR 119301037 LAG SCR 12.7D X 90MM STAN 119301040 LAG SCR 12.7D X 95MM STAN 119301542 LAG SCR 15.8D X 100MM LAR 119301545 LAG SCR 15.8D X 105MM LAR 119301547 LAG SCR 15.8D X 110MM LAR 119301550 LAG SCR 15.8D X 115MM LAR 119301552 LAG SCR 15.8D X 120MM LAR 119301555 LAG SCR 15.8D X 125MM LAR 119301557 LAG SCR 15.8D X 130MM LAR 119301520 LAG SCR 15.8D X 55MM LARG 119301522 LAG SCR 15.8D X 60MM LARG 119301525 LAG SCR 15.8D X 65MM LARG 119301532 LAG SCR 15.8D X 80MM LARG 119301535 LAG SCR 15.8D X 85MM LARG 119301537 LAG SCR 15.8D X 90MM LARG Product Usage: Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Class I - Dangerous

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Jan 11, 2016 Implants & Prosthetics Nationwide View Details →

Product 32 consists of all product under product code: HWC and same usage: Item no: 47115401200 HERBERT BONE SCREW, 3.0MM 47115401400 HERBERT BONE SCREW, 3.0MM 47115401600 HERBERT BONE SCREW, 3.0MM 47115401800 HERBERT BONE SCREW, 3.0MM 47115402000 HERBERT BONE SCREW, 3.0MM 47115402200 HERBERT BONE SCREW, 3.0MM 47115402400 HERBERT BONE SCREW, 3.0MM 47115402600 HERBERT BONE SCREW, 3.0MM 47115402800 HERBERT BONE SCREW, 3.0MM 47115403000 HERBERT BONE SCREW, 3.0MM 47115502505 HERBERT CANNULATED BONE S 47115503005 HERBERT CANNULATED BONE S 47115503505 HERBERT CANNULATED BONE S 47115504005 HERBERT CANNULATED BONE S 47115504007 HERBERT CANNULATED BONE S 47115504505 HERBERT CANNULATED BONE S 47115504507 HERBERT CANNULATED BONE S 47115505005 HERBERT CANNULATED BONE S 47115505007 HERBERT CANNULATED BONE S 47115505505 HERBERT CANNULATED BONE S 47115505507 HERBERT CANNULATED BONE S 47115506005 HERBERT CANNULATED BONE S 47115506007 HERBERT CANNULATED BONE S 47115506505 HERBERT CANNULATED BONE S 47115506507 HERBERT CANNULATED BONE S 47115507005 HERBERT CANNULATED BONE S 47115507007 HERBERT CANNULATED BONE S 47115507505 HERBERT CANNULATED BONE S 47115507507 HERBERT CANNULATED BONE S 47115508005 HERBERT CANNULATED BONE S 47115508007 HERBERT CANNULATED BONE S 47115508505 HERBERT CANNULATED BONE S 47115508507 HERBERT CANNULATED BONE S 47115509005 HERBERT CANNULATED BONE S 47115509007 HERBERT CANNULATED BONE S 47115509505 HERBERT CANNULATED BONE S 47115509507 HERBERT CANNULATED BONE S 47115510005 HERBERT CANNULATED BONE S 47115510007 HERBERT CANNULATED BONE S 115001000 HERBERT MINI BONE SCREW 2 115001200 HERBERT MINI BONE SCREW 2 115001400 HERBERT MINI BONE SCREW 2 115001600 HERBERT MINI BONE SCREW 2 115001800 HERBERT MINI BONE SCREW 2 115002000 HERBERT MINI BONE SCREW 2 115002200 HERBERT MINI BONE SCREW 2 115002400 HERBERT MINI BONE SCREW 2 115201200 HERBERT/WHIPPLE CANN BONE 115201400 HERBERT/WHIPPLE CANN BONE 115201600 HERBERT/WHIPPLE CANN BONE 115201800 HERBERT/WHIPPLE CANN BONE 115202000 HERBERT/WHIPPLE CANN BONE 115202200 HERBERT/WHIPPLE CANN BONE 115202400 HERBERT/WHIPPLE CANN BONE 115202600 HERBERT/WHIPPLE CANN BONE 115202800 HERBERT/WHIPPLE CANN BONE 115203000 HERBERT/WHIPPLE CANN BONE Product Usage: A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Class I - Dangerous

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Jan 11, 2016 Implants & Prosthetics Nationwide View Details →

Product 50 consists of all product under product code: JWH and same usage: Item no: 595002701 NEXGEN MIS TIBIA PLATE PR 595002702 NEXGEN MIS TIBIA PLATE PR 595003701 NEXGEN MIS TIBIA PLATE PR 595003702 NEXGEN MIS TIBIA PLATE PR 595003712 NEXGEN MIS TIBIA PLATE PR 595004701 NEXGEN MIS TIBIA PLATE PR 595004702 NEXGEN MIS TIBIA PLATE PR 595005701 NEXGEN MIS TIBIA PLATE PR 595005702 NEXGEN MIS TIBIA PLATE PR for use in total knee arthroplasty

Class I - Dangerous

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Jan 11, 2016 Implants & Prosthetics Nationwide View Details →

Product 57 consists of all product code: JDI and same usage: Item no: 763401000 PRESSFIT FEM ST FX 10 X 115 763401100 PRESSFIT FEM ST FX 11 X 1 763401200 PRESSFIT FEM ST FX 12 X 1 763401300 PRESSFIT FEM ST FX 13 X 1 763401400 PRESSFIT FEM ST FX 14 X 1 763401500 PRESSFIT FEM ST FX 15 X 1 For use in total or hemi hip arthroplasty

Class I - Dangerous

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Jan 11, 2016 Implants & Prosthetics Nationwide View Details →

Product 11 consists of all product under product code JDI , and same usage: Item no: 902602500 6 DEGREE COCR FEM HEAD 26 902602600 6 DEGREE COCR FEM HEAD 26 902602700 6 DEGREE COCR FEM HEAD 26 902602800 6 DEGREE COCR FEM HEAD 28 902602900 6 DEGREE COCR FEM HEAD 28 902603000 6 DEGREE COCR FEM HEAD 28 902603300 6 DEGREE COCR FEM HEAD 32 902603200 6 DEGREE COCR FEM HEAD 32 Product Usage: For use in total or hemi hip arthroplasty

Class I - Dangerous

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Jan 11, 2016 Implants & Prosthetics Nationwide View Details →

Product 33 consists of all product under product code: JDI and same usage: Item no: 662406515 HGP II ACETABULAR CUP BON 662406520 HGP II ACETABULAR CUP BON 662406525 HGP II ACETABULAR CUP BON 662406530 HGP II ACETABULAR CUP BON 662406535 HGP II ACETABULAR CUP BON 662406540 HGP II ACETABULAR CUP BON 662406550 HGP II ACETABULAR CUP BON 662406560 HGP II ACETABULAR CUP BON For use in total hip arthroplasty

Class I - Dangerous

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Jan 11, 2016 Implants & Prosthetics Nationwide View Details →

Product 38 consists of all product under product code: HSB and same usage: Item no: 225303255 INTERLOCKING IM SCREW LG 225303555 INTERLOCKING IM SCREW LG 225303755 INTERLOCKING IM SCREW LG 225307055 INTERLOCKING IM SCREW LG 225302742 INTERLOCKING IM SCREW MED 225303242 INTERLOCKING IM SCREW MED 225307042 INTERLOCKING IM SCREW MED 225302737 INTERLOCKING IM SCREW SML 225303237 INTERLOCKING IM SCREW SML Product Usage: An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.

Class I - Dangerous

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Jan 11, 2016 Implants & Prosthetics Nationwide View Details →

Product 58 consists of all product under product code: HRS and same usage: Item no: 234800904 PROXIMAL DORSAL ULNA PLT 234800906 PROXIMAL DORSAL ULNA PLT 234800908 PROXIMAL DORSAL ULNA PLT 234800910 PROXIMAL DORSAL ULNA PLT 234801004 PROXIMAL DORSAL ULNA PLT 234801006 PROXIMAL DORSAL ULNA PLT 234801008 PROXIMAL DORSAL ULNA PLT 234801010 PROXIMAL DORSAL ULNA PLT 10H LT 234701304 PROXIMAL MEDIAL TIBIAL 4. 234701306 PROXIMAL MEDIAL TIBIAL 4. 234701308 PROXIMAL MEDIAL TIBIAL 4. 234701404 PROXIMAL MEDIAL TIBIAL 4. 234701406 PROXIMAL MEDIAL TIBIAL 4. 234701408 PROXIMAL MEDIAL TIBIAL 4. Usage: Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Class I - Dangerous

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

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Product 55 consists of all product under product code: HSB and same usage: Item no: 225900132 ONE-PIECE LAG SCREW 11MM 225900135 ONE-PIECE LAG SCREW 11MM 225900137 ONE-PIECE LAG SCREW 11MM 225900140 ONE-PIECE LAG SCREW 11MM 225900142 ONE-PIECE LAG SCREW 11MM 225900145 ONE-PIECE LAG SCREW 11MM 225900152 ONE-PIECE LAG SCREW 11MM Usage: An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.

Class I - Dangerous

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Jan 11, 2016 Implants & Prosthetics Nationwide View Details →

Product 6 consists of all products under product code HWC, and same usage: Item no: 47493501001 3.5 X 10 CORT SCREW SELFT 47493501801 3.5 X 18 CORT SCREW SELFT Product Usage: A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Class I - Dangerous

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Jan 11, 2016 Implants & Prosthetics Nationwide View Details →

Product 2 consists of all products product code LPH, and same usage: 801802202 12/14 COCR FEMORAL HEAD 2 801802220 12/14 COCR FEMORAL HEAD 2 801802230 12/14 COCR FEMORAL HEAD 2 801802601 12/14 COCR FEMORAL HEAD 2 801802602 12/14 COCR FEMORAL HEAD 2 801802603 12/14 COCR FEMORAL HEAD 2 801802604 12/14 COCR FEMORAL HEAD 2 801802605 12/14 COCR FEMORAL HEAD 2 801802801 12/14 COCR FEMORAL HEAD 2 801802802 12/14 COCR FEMORAL HEAD 2 801802803 12/14 COCR FEMORAL HEAD 2 801802805 12/14 COCR FEMORAL HEAD 2 801802814 12/14 COCR FEMORAL HEAD 2 801803201 12/14 COCR FEMORAL HEAD 3 801803202 12/14 COCR FEMORAL HEAD 3 801803203 12/14 COCR FEMORAL HEAD 3 801803205 12/14 COCR FEMORAL HEAD 3 801803214 12/14 COCR FEMORAL HEAD 3 801803601 12/14 COCR FEMORAL HEAD 3 801803602 12/14 COCR FEMORAL HEAD 3 801803603 12/14 COCR FEMORAL HEAD 3 801803604 12/14 COCR FEMORAL HEAD 3 801803605 12/14 COCR FEMORAL HEAD 3 801804001 12/14 COCR FEMORAL HEAD 4 801804002 12/14 COCR FEMORAL HEAD 4 801804003 12/14 COCR FEMORAL HEAD 4 801804004 12/14 COCR FEMORAL HEAD 4 902602100 6 DEGREE COCR FEM HEAD 22 32902603935 FEM HD 26MMDIA SHT NK+ 32902603800 FEMORAL HEAD +0.5 X 22 MM 32902604810 FEMORAL HEAD +3.5 X 22 MM 32902604845 FEMORAL HEAD +7.0 X 22 MM For use in total or hemi hip arthroplasty

Class I - Dangerous

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Jan 11, 2016 Implants & Prosthetics Nationwide View Details →

Product 68 consists of all product under product code: JDI and same usage: Item no: 787101360 VERSYS CEM/REV/CALCAR 13X 787101361 VERSYS CEM/REV/CALCAR 13X 787101362 VERSYS CEM/REV/CALCAR 13X 787101363 VERSYS CEM/REV/CALCAR 13X 787101560 VERSYS CEM/REV/CALCAR 15X 787101561 VERSYS CEM/REV/CALCAR 15X 787101562 VERSYS CEM/REV/CALCAR 15X 787101563 VERSYS CEM/REV/CALCAR 15X 787101760 VERSYS CEM/REV/CALCAR 17X 787101761 VERSYS CEM/REV/CALCAR 17X 787101761 VERSYS CEM/REV/CALCAR 17X For use in total or hemi hip arthroplasty

Class I - Dangerous

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Jan 11, 2016 Implants & Prosthetics Nationwide View Details →

Product 21 consists of all product under product code: JDI and same usage: Item no: 811400218 CPT 12/14 COCR REVISION S 811400318 CPT 12/14 COCR REVISION S 811400420 CPT 12/14 COCR REVISION S 811400423 CPT 12/14 COCR REVISION S 811400426 CPT 12/14 COCR REVISION S 811400010 CPT 12/14 COCR SIZE 0 EXT 811400000 CPT 12/14 COCR SIZE 0 STD 811400110 CPT 12/14 COCR SIZE 1 EXT 811400100 CPT 12/14 COCR SIZE 1 STD 811400210 CPT 12/14 COCR SIZE 2 EXT 811400200 CPT 12/14 COCR SIZE 2 STD 811400230 CPT 12/14 COCR SIZE 2 XEX 811400310 CPT 12/14 COCR SIZE 3 EXT 811400300 CPT 12/14 COCR SIZE 3 STD 811400330 CPT 12/14 COCR SIZE 3 XEX 811400410 CPT 12/14 COCR SIZE 4 EXT 811400400 CPT 12/14 COCR SIZE 4 STD 811400430 CPT 12/14 COCR SIZE 4 XEX 811400510 CPT 12/14 COCR SIZE 5 EXT 811400500 CPT 12/14 COCR SIZE 5 STD 811400530 CPT 12/14 COCR SIZE 5 XEX Product Usage: Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Class I - Dangerous

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Jan 11, 2016 Implants & Prosthetics Nationwide View Details →

Product 23 consists of all product code: JDI and same usage: Item no: 801100220 CPT 2 HIP STEM, X-OFFSET 801100320 CPT 3 HIP STEM, X-OFFSET 801100420 CPT 4 HIP STEM, X-OFFSET 801100005 CPT HIP STEM PETITE 801100700 CPT HIP STEM SZ 2 LONG 801100800 CPT HIP STEM SZ 3 LONG 801100222 CPT MOD HD ST/ST 22MED SH 801100322 CPT MOD HD ST/ST 22MMD LN 801100122 CPT MOD HD ST/ST 22MMD SH 801100126 CPT MOD HD ST/ST 26MMD SH 801100328 CPT MOD HD ST/ST 28MMD LN 801100228 CPT MOD HD ST/ST 28MMD ME 801100128 CPT MOD HD ST/ST 28MMD SH 801100332 CPT MOD HD ST/ST 32MMD LN 801100232 CPT MOD HD ST/ST 32MMD ME 801100132 CPT MOD HD ST/ST 32MMD SH 801100100 CPT MODULAR STEM SIZE 1 S 801100200 CPT MODULAR STEM SIZE 2 S 801100300 CPT MODULAR STEM SIZE 3 S 801100400 CPT MODULAR STEM SIZE 4 S 801100500 CPT MODULAR STEM SIZE 5 S For use in total or hemi hip arthroplasty

Class I - Dangerous

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Jan 11, 2016 Implants & Prosthetics Nationwide View Details →

Product 44 consists of all product under product code: HWC and same usage: Item no: 114607099 MAGMA-FX CANN SCREW 7.0MM 114604099 MAGNA FX CANN SCREW 7.0MM 114603000 MAGNA-FX CANN SCREW 7.0MM 114603500 MAGNA-FX CANN SCREW 7.0MM 114604000 MAGNA-FX CANN SCREW 7.0MM 114604032 MAGNA-FX CANN SCREW 7.0MM 114604500 MAGNA-FX CANN SCREW 7.0MM 114604532 MAGNA-FX CANN SCREW 7.0MM 114604599 MAGNA-FX CANN SCREW 7.0MM 114605000 MAGNA-FX CANN SCREW 7.0MM 114605032 MAGNA-FX CANN SCREW 7.0MM 114605099 MAGNA-FX CANN SCREW 7.0MM 114605500 MAGNA-FX CANN SCREW 7.0MM 114605532 MAGNA-FX CANN SCREW 7.0MM 114605599 MAGNA-FX CANN SCREW 7.0MM 114606000 MAGNA-FX CANN SCREW 7.0MM 114606032 MAGNA-FX CANN SCREW 7.0MM 114606099 MAGNA-FX CANN SCREW 7.0MM 114606500 MAGNA-FX CANN SCREW 7.0MM 114606532 MAGNA-FX CANN SCREW 7.0MM 114606599 MAGNA-FX CANN SCREW 7.0MM 114607000 MAGNA-FX CANN SCREW 7.0MM 114607032 MAGNA-FX CANN SCREW 7.0MM 114607500 MAGNA-FX CANN SCREW 7.0MM 114607532 MAGNA-FX CANN SCREW 7.0MM 114607599 MAGNA-FX CANN SCREW 7.0MM 114608000 MAGNA-FX CANN SCREW 7.0MM 114608032 MAGNA-FX CANN SCREW 7.0MM 114608099 MAGNA-FX CANN SCREW 7.0MM 114608500 MAGNA-FX CANN SCREW 7.0MM 114608532 MAGNA-FX CANN SCREW 7.0MM 114608599 MAGNA-FX CANN SCREW 7.0MM 114609000 MAGNA-FX CANN SCREW 7.0MM 114609032 MAGNA-FX CANN SCREW 7.0MM 114609099 MAGNA-FX CANN SCREW 7.0MM 114609500 MAGNA-FX CANN SCREW 7.0MM 114609532 MAGNA-FX CANN SCREW 7.0MM 114609599 MAGNA-FX CANN SCREW 7.0MM 114610000 MAGNA-FX CANN SCREW 7.0MM 114610032 MAGNA-FX CANN SCREW 7.0MM 114610099 MAGNA-FX CANN SCREW 7.0MM 114610500 MAGNA-FX CANN SCREW 7.0MM 114610532 MAGNA-FX CANN SCREW 7.0MM 114610599 MAGNA-FX CANN SCREW 7.0MM 114611000 MAGNA-FX CANN SCREW 7.0MM 114611032 MAGNA-FX CANN SCREW 7.0MM 114611099 MAGNA-FX CANN SCREW 7.0MM 114611500 MAGNA-FX CANN SCREW 7.0MM 114611532 MAGNA-FX CANN SCREW 7.0MM 114611599 MAGNA-FX CANN SCREW 7.0MM 114612000 MAGNA-FX CANN SCREW 7.0MM 114612032 MAGNA-FX CANN SCREW 7.0MM 114612500 MAGNA-FX CANN SCREW 7.0MM 114612599 MAGNA-FX CANN SCREW 7.0MM 114613000 MAGNA-FX CANN SCREW 7.0MM 114613099 MAGNA-FX CANN SCREW 7.0MM 511007020 MGII KNEE SLF-TAP BONE ST 511007025 MGII KNEE SLF-TAP BONE ST 511007030 MGII KNEE SLF-TAP BONE ST 511007035 MGII KNEE SLF-TAP BONE ST 511007040 MGII KNEE SLF-TAP BONE ST 511007045 MGII KNEE SLF-TAP BONE ST 114204012 MINI MAGNA-FX CANN SCREW 114204016 MINI MAGNA-FX CANN SCREW 114204020 MINI MAGNA-FX CANN SCREW 114204024 MINI MAGNA-FX CANN SCREW 114204028 MINI MAGNA-FX CANN SCREW 114204032 MINI MAGNA-FX CANN SCREW 114204036 MINI MAGNA-FX CANN SCREW 114204040 MINI MAGNA-FX CANN SCREW 114204044 MINI MAGNA-FX CANN SCREW 114204048 MINI MAGNA-FX CANN SCREW 114204055 MINI MAGNA-FX CANN SCREW 114204065 MINI MAGNA-FX CANN SCREW 114204124 MINI MAGNA-FX CANN SCREW 114204126 MINI MAGNA-FX CANN SCREW 114204128 MINI MAGNA-FX CANN SCREW 114204130 MINI MAGNA-FX CANN SCREW 114204132 MINI MAGNA-FX CANN SCREW 114204134 MINI MAGNA-FX CANN SCREW 114204136 MINI MAGNA-FX CANN SCREW 114204138 MINI MAGNA-FX CANN SCREW 114204140 MINI MAGNA-FX CANN SCREW 114204142 MINI MAGNA-FX CANN SCREW 114204144 MINI MAGNA-FX CANN SCREW 114204146 MINI MAGNA-FX CANN SCREW 114204148 MINI MAGNA-FX CANN SCREW 114204150 MINI MAGNA-FX CANN SCREW 114204155 MINI MAGNA-FX CANN SCREW 114204160 MINI MAGNA-FX CANN SCREW 114204165 MINI MAGNA-FX CANN SCREW 114204170 MINI MAGNA-FX CANN SCREW 114205012 MINI MAGNA-FX CANN SCREW 114205016 MINI MAGNA-FX CANN SCREW 114205020 MINI MAGNA-FX CANN SCREW 114205024 MINI MAGNA-FX CANN SCREW 114205028 MINI MAGNA-FX CANN SCREW 114205032 MINI MAGNA-FX CANN SCREW 114205036 MINI MAGNA-FX CANN SCREW 114205040 MINI MAGNA-FX CANN SCREW 114205044 MINI MAGNA-FX CANN SCREW 114205048 MINI MAGNA-FX CANN SCREW 114205055 MINI MAGNA-FX CANN SCREW 114205065 MINI MAGNA-FX CANN SCREW 114205124 MINI MAGNA-FX CANN SCREW 114205126 MINI MAGNA-FX CANN SCREW 114205128 MINI MAGNA-FX CANN SCREW

Class I - Dangerous

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Jan 11, 2016 Implants & Prosthetics Nationwide View Details →

Product 24 consists of all product under product code: HRS and same usage: Item no: 234703104 DISTAL MEDIAL FEMORAL CON 234703206 DISTAL MEDIAL FEMORAL CON 234703208 DISTAL MEDIAL FEMORAL CON 234800504 DISTAL POSTERIOR/LATERAL 234800506 DISTAL POSTERIOR/LATERAL 234800508 DISTAL POSTERIOR/LATERAL 234800510 DISTAL POSTERIOR/LATERAL 234800604 DISTAL POSTERIOR/LATERAL 234800606 DISTAL POSTERIOR/LATERAL 234800608 DISTAL POSTERIOR/LATERAL 234800610 DISTAL POSTERIOR/LATERAL 234800614 DISTAL POSTERIOR/LATERAL Product Usage: Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Class I - Dangerous

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Jan 11, 2016 Implants & Prosthetics Nationwide View Details →

Label reading in part as: "NexGen System, Complete Knee Solution; Reference Number 5980-37-01; Tibial Component, Precoat, Stemmed Size 3; Lot Number:62460264. Indicated for patients with severe knee pain and disability and is intended for mating with a UHMWPE articular surface and Zimaloy Cobalt-Chromium-Molybdenum alloy femoral component to perform knee arthroplasty.

Class I - Dangerous

Complaints were received from Thailand reporting that there was no white paper (Tyvek) seal on the inner package of P/N:00-5980-037-01 unit from lot #62460264

Dec 2, 2015 Implants & Prosthetics View Details →

Trilogy¿ Fiber Metal Acetabular Shell Size 54 mm OD The Trilogy Acetabular System is indicated for either cemented or uncemented use in skeletally mature individuals undergoing primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

Class I - Dangerous

Zimmer received a single complaint wherein a Trilogy® Fiber Metal Multi-Hole Acetabular Shell would not attach to the inserter/impactor instrumentation. Subsequent investigation found the polar-hole threads to be present but non-conforming to specifications, in that the minor diameter was undersized. Investigation also indicates that the issue is isolated and affects only lot 62714305, which

Dec 4, 2014 Implants & Prosthetics Nationwide View Details →

Bone Screw, self-tapping The Trilogy shells are available in three configurations; uni, multi, and cluster-holed. The multi and cluster-holed shells allow for the use of screws to provide additional fixation and security, particularly in those case where acetabular bone stock is deficient. The Trilogy Acetabular System is indicated for either cemented or uncemented use in skeletally mature individuals undergoing primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

Class I - Dangerous

Analysis of returned complaint devices, product in inventory, and device manufacturing records has identified tool marks isolated to one specific machining mill to be the cause of the fractures. .

Nov 21, 2014 Implants & Prosthetics Nationwide View Details →

Zimmer EDI PERIARTICULAR PLATING SYSTEM CANCELLOUS BONE SCREW, FULLY THREADED, HEX HEAD 4MM DIAMETER, 14 MM LENGTH, and EDI 4.0 MM CANCELLOUS SCREW, FULLY THREADED, 20 MM LENGTH. Temporary internal fixation devices, designed to stabilize fractures during the normal healing process.

Class I - Dangerous

Two lots of screws were commingled. Screws with etching and machining for lot number 62629432 were packaged in bags labeled for lot number 62628759; and screws with etching and machining for lot number 62628759 were packaged in bags labeled for lot number 62629432. The affected product was distributed between 3/6/14 and 4/21/14.

Jun 12, 2014 Diagnostic Equipment Nationwide View Details →