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Medical Devices Recalls

Medical equipment, implants, and diagnostic devices

38,779 Total Recalls

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

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 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.

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 →

Accu-Chek Inform II Base Unit as a part of the Accu-Chek Inform II Blood Glucose Monitoring System Accu-Chek inform II Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings. This system should only be use with single-use, auto-disabling lancing devices.

Roche Diagnostics Operations

Class I - Dangerous

Accu-Chek Inform II Base Unit might produce physical transmission errors in the form of data loss in the communication between the meter and the Data Management Systems (DMS). The issue can lead to the data loss or in the worst case to an erroneous assignment of the patient data (patient mismatch). The issue will only occur at sites using POTCT1-A communication via USB.

Feb 11, 2016 Diagnostic Equipment 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.

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 28 consists of all product under product code: JDI and same usage: Item no: 32902605000 FEMORAL HD 28MM MEDIUM 32902604000 FEMORAL HD 28MM SHORT 32902604035 FEMORAL HD 28MM SHT+ 3.5M 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 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

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 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.

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 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

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 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

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 34 consists of all product under product code: JWH and same usage: Item no: 522001700 I/B II KNEE DOMED PATELLA 522001800 I/B II KNEE DOMED PATELLA 522001900 I/B II KNEE DOMED PATELLA 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 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

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 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.

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 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.

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 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.

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 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

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 →