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Implants & Prosthetics

🏥 Medical Devices • 4,540 recalls

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.

Zimmer Manufacturing B.V.

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.

Zimmer Manufacturing B.V.

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.

Zimmer Manufacturing B.V.

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.

Zimmer Manufacturing B.V.

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

Zimmer Manufacturing B.V.

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

Zimmer Manufacturing B.V.

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.

Zimmer Manufacturing B.V.

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 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.

Zimmer Manufacturing B.V.

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

Zimmer Manufacturing B.V.

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 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.

Zimmer Manufacturing B.V.

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 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

Zimmer Manufacturing B.V.

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 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.

Zimmer Manufacturing B.V.

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 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.

Zimmer Manufacturing B.V.

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 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

Zimmer Manufacturing B.V.

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 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

Zimmer Manufacturing B.V.

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

Zimmer Manufacturing B.V.

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 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

Zimmer Manufacturing B.V.

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 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.

Zimmer Manufacturing B.V.

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

Zimmer Manufacturing B.V.

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 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.

Zimmer Manufacturing B.V.

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 →

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