FDA (Devices) recall action 72900

Zimmer Manufacturing B.V. recalled 72 products on 2016-03-23

The FDA (Devices) publishes a recall like this one as 72 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 72 pages.

Products: 72
Announced: 2016-03-23
Critical: 0
Units: 665,035

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

26–50 of 72

ModerateFDA (Devices)··2016-03-23
Zimmer Manufacturing Recalls Sterile Femoral Heads Due to Sealer Calibration Issues
Zimmer Manufacturing B.V. is recalling specific sterile femoral heads used in hip arthroplasty due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.
Product
Product 29 consists of all product under product code: LPHand same usage: Item no: 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
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ModerateFDA (Devices)··2016-03-23
Zimmer Manufacturing Recalls 2.7mm Cortical Screws Due to Sealer Calibration Issues
Zimmer Manufacturing B.V. is recalling 60 sterile 2.7mm cortical screws due to insufficient sealer calibration data. The products were distributed nationwide in the US.
Product
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 18M
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ModerateFDA (Devices)··2016-03-23
Zimmer Manufacturing Recalls Sterile Knee Patella Components Due to Sealer Calibration
Zimmer Manufacturing B.V. is recalling 512 sterile I/B II Knee Domed Patella components for total knee arthroplasty due to insufficient sealer calibration data.
Product
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
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ModerateFDA (Devices)··2016-03-23
Zimmer Manufacturing Recalls Sterile Bone Fixation Screws Due to Sealer Calibration
Zimmer Manufacturing B.V. is recalling sterile 1.5 x 6 Cortical Screws due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.
Product
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 ma
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ModerateFDA (Devices)··2016-03-23
Zimmer Manufacturing Recalls Sterile Cortical Screws Due to Sealer Calibration Issues
Zimmer Manufacturing B.V. is recalling 109 sterile 3.5mm cortical screws due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.
Product
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
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ModerateFDA (Devices)··2016-03-23
Zimmer Manufacturing Recalls 3.5mm Cortical Screws Due to Sealer Calibration Issues
Zimmer Manufacturing B.V. is recalling 99 units of 3.5mm cortical screws due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.
Product
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
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ModerateFDA (Devices)··2016-03-23
Zimmer Manufacturing Recalls Bipolar Hip Liners Due to Sealer Calibration Issues
Zimmer Manufacturing B.V. is recalling 8,773 units of bipolar liners and shells for hip arthroplasty due to insufficient sealer calibration data.
Product
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
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ModerateFDA (Devices)··2016-03-23
Zimmer Manufacturing Recalls Mini Magna-FX Cann Screws Due to Calibration Data Issues
Zimmer Manufacturing B.V. is recalling 3,190 units of Mini Magna-FX Cann Screws because of insufficient sealer calibration data for products packaged between August 2010 and April 2013.
Product
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 MI
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HighFDA (Devices)··2016-03-23
Zimmer Versys Advocate Hip Implants Recalled for Calibration Issues
Zimmer Manufacturing B.V. is recalling Versys Advocate hip implants due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.
Product
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 VER
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ModerateFDA (Devices)··2016-03-23
Zimmer Manufacturing Recalls Hip Arthroplasty Components Due to Sealer Calibration Issues
Zimmer Manufacturing B.V. is recalling specific hip arthroplasty components due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.
Product
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 811400
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ModerateFDA (Devices)··2016-03-23
Zimmer NexGen All-Poly Patella Components Recalled for Calibration Issues
Zimmer Manufacturing B.V. is recalling NexGen All-Poly Patella and related knee arthroplasty components due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.
Product
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 NE
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ModerateFDA (Devices)··2016-03-23
Zimmer Manufacturing Recalls Sterile Orthopedic Fixation Devices Due to Calibration Issues
Zimmer Manufacturing B.V. is recalling specific sterile orthopedic fixation devices due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.
Product
Product 9 consists of all product under HRS, and same usage: Item no: 47494502601 4.5 BROAD SCP PLT, 26 HOL Product Usage: Temporary internal fixation devices designed to stabilize fractures during the normal healing process.
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ModerateFDA (Devices)··2016-03-23
Zimmer Manufacturing Recalls Pressfit Femoral Stems Due to Sealer Calibration
Zimmer Manufacturing B.V. is recalling sterile pressfit femoral stems used in hip arthroplasty due to insufficient sealer calibration data.
Product
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 F
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ModerateFDA (Devices)··2016-03-23
Zimmer Versys Hip Implant Recall Due to Insufficient Sealer Calibration Data
Zimmer Manufacturing B.V. is recalling 1,220 units of Versus hip implants due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.
Product
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 78710156
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ModerateFDA (Devices)··2016-03-23
Zimmer Manufacturing Recalls Distal Femoral Bone Fixation Appliances
Zimmer Manufacturing B.V. is recalling 37 sterile distal femoral bone fixation appliances due to insufficient sealer calibration data.
Product
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
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ModerateFDA (Devices)··2016-03-23
Zimmer Distal Femoral Components Recalled for Sterility Concerns
Zimmer Manufacturing B.V. is recalling specific distal femoral components used in hip arthroplasty due to insufficient sealer calibration data.
Product
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
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HighFDA (Devices)··2016-03-23
Zimmer NexGen MIS Tibia Plate Recall for Sterility Concerns
Zimmer Manufacturing B.V. is recalling NexGen MIS Tibia Plates due to insufficient sealer calibration data, raising concerns about the sterility of the devices.
Product
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 5950047
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ModerateFDA (Devices)··2016-03-23
Zimmer Manufacturing Recalls Sterile Bone Fixation Screws Due to Sealer Calibration
Zimmer Manufacturing B.V. is recalling 154 sterile bone fixation screws distributed nationwide due to insufficient sealer calibration data.
Product
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 CRUC
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ModerateFDA (Devices)··2016-03-23
Zimmer Manufacturing Recalls Interlocking Intramedullary Screws Due to Calibration Issues
Zimmer Manufacturing B.V. is recalling 1,777 sterile interlocking intramedullary screws due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.
Product
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 IN
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ModerateFDA (Devices)··2016-03-23
Zimmer Manufacturing Recalls Sterile Femoral and Humeral Intramedullary Nails
Zimmer Manufacturing B.V. is recalling 1,622 sterile femoral and humeral intramedullary nails due to insufficient sealer calibration data.
Product
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 2252360
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ModerateFDA (Devices)··2016-03-23
Zimmer NexGen All-Poly Patella Recalled for Sterility Concerns
Zimmer Manufacturing B.V. is recalling NexGen All-Poly Patella implants due to insufficient sealer calibration data affecting sterility.
Product
Product 48 consists of all product under product code: JWH and same usage: Item no: 597206526 NEXGEN ALL-POLY PATELLA, for use in total knee arthroplasty
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HighFDA (Devices)··2016-03-23
Zimmer NexGen Osteotomy Cortical Bone Screws Recalled for Sterility Concerns
Zimmer Manufacturing B.V. is recalling NexGen Osteotomy Cortical Bone Screws due to insufficient sealer calibration data, raising concerns about the sterility of the devices.
Product
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 ar
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ModerateFDA (Devices)··2016-03-23
Zimmer Manufacturing Recalls 83 Sterile Bone Fixation Screws
Zimmer Manufacturing B.V. is recalling 83 sterile bone fixation screws due to insufficient sealer calibration data. The products were distributed nationwide in the US.
Product
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 4
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ModerateFDA (Devices)··2016-03-23
Zimmer Manufacturing Recalls Interlocking IM Screws Due to Sealer Calibration Issues
Zimmer Manufacturing B.V. is recalling 268 units of Interlocking IM Screws 4.5 due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.
Product
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 2253040
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ModerateFDA (Devices)··2016-03-23
Zimmer Manufacturing Recalls Sterile Bone Screws Due to Calibration Issues
Zimmer Manufacturing B.V. is recalling sterile bone screws used in hip arthroplasty due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.
Product
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 625004
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