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.

1–25 of 72

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…
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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…
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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…
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ModerateFDA (Devices)··2016-03-23
Zimmer Manufacturing Recalls One-Piece Lag Screws Due to Sealer Calibration Issues
Zimmer Manufacturing B.V. is recalling 58,320 sterile one-piece lag screws due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.
Product
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…
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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…
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ModerateFDA (Devices)··2016-03-23
Zimmer Versys Advocate Cemented Hip Implants Recalled for Calibration Data Issues
Zimmer Manufacturing B.V. is recalling 5,013 units of Versys Advocate Cemented hip implants due to insufficient sealer calibration data. The affected sterile products were distributed nationwide.
Product
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…
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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…
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ModerateFDA (Devices)··2016-03-23
Zimmer Precoat Tibia Plates Recalled for Sealer Calibration Issues
Zimmer Manufacturing B.V. is recalling 39 sterile precoat tibia plates used in total knee arthroplasty due to insufficient sealer calibration data.
Product
Product 61 consists of all product under product code: JWH and same usage: Item no: 598003712 STD PRECOAT TIBIA PLATE S for use in total knee arthroplasty
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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…
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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…
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HighFDA (Devices)··2016-03-23
Zimmer Manufacturing Recalls Trilogy Acet Shells Due to Calibration Issues
Zimmer Manufacturing B.V. is recalling 2,063 units of Trilogy Acet Shells used in total hip arthroplasty due to insufficient sealer calibration data.
Product
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…
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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…
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HighFDA (Devices)··2016-03-23
Zimmer Manufacturing Recalls Unipolar Femoral Heads Due to Sterility Concerns
Zimmer Manufacturing B.V. is recalling 2,239 unipolar femoral heads used in hip arthroplasty due to insufficient sealer calibration data, raising concerns about the sterility of the devices.
Product
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…
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HighFDA (Devices)··2016-03-23
Zimmer Manufacturing Recalls Sterile Knee Fluted Rods Due to Sealer Calibration
Zimmer Manufacturing B.V. is recalling 49 units of sterile I/B II Knee Fluted Rods due to insufficient sealer calibration data.
Product
Product 35 consists of all product under product code: JWH and same usage: Item no: 522007300 I/B II KNEE FLUTED ROD, 1 for use in total knee arthroplasty
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HighFDA (Devices)··2016-03-23
Zimmer Manufacturing Recalls Hip Femoral Heads Due to Calibration Issues
Zimmer Manufacturing B.V. is recalling 35,032 hip femoral heads due to insufficient sealer calibration data. The affected sterile products were packaged between August 2010 and April 2013.
Product
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…
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ModerateFDA (Devices)··2016-03-23
Zimmer Manufacturing Recalls Distal Femoral Components Due to Calibration Data Issues
Zimmer Manufacturing B.V. is recalling 945 units of distal femoral components due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.
Product
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…
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ModerateFDA (Devices)··2016-03-23
Zimmer Zimtron Hip Arthroplasty Heads Recalled for Sealer Calibration Issues
Zimmer Manufacturing B.V. is recalling 226 sterile Zimtron hip arthroplasty heads due to insufficient sealer calibration data. The affected units were packaged between August 2010 and April 2013.
Product
Product 72 consists of all product code: JDI and same usage: Item no: 805002202 ZIMTRON HEAD 12/14 0X22 MM For use in total or hemi hip arthroplasty
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HighFDA (Devices)··2016-03-23
Zimmer Manufacturing Recalls Sterile Femoral Hip Implant Components
Zimmer Manufacturing B.V. is recalling specific sterile femoral hip implant components due to insufficient sealer calibration data.
Product
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
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HighFDA (Devices)··2016-03-23
Zimmer Ion Implanted Femoral Stems Recalled for Sterility Concerns
Zimmer Manufacturing B.V. is recalling 17 ion implanted femoral stems used in hip arthroplasty due to insufficient sealer calibration data affecting sterility.
Product
Product 39 consists of all product under product code: JDI and same usage: Item no: 32902605800 ION IMPLANTED FEM 22MM LO 32902604900 ION IMPLANTED FEM 26MM ME 32902603900 ION IMPLANTED FEM 26MM SH For use in total or hemi hip arthroplasty
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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…
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ModerateFDA (Devices)··2016-03-23
Zimmer Manufacturing Recalls Sterile Knee Arthroplasty Bone Screws
Zimmer Manufacturing B.V. is recalling 3,696 sterile MGII Knee Self-Tap Bone Screws due to insufficient sealer calibration data.
Product
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…
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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…
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ModerateFDA (Devices)··2016-03-23
Zimmer Manufacturing Recalls Sterile Hip Arthroplasty Stems Due to Calibration Issues
Zimmer Manufacturing B.V. is recalling sterile cemented femoral stems for hip arthroplasty due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.
Product
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…
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ModerateFDA (Devices)··2016-03-23
Zimmer Manufacturing Recalls Sterile Intramedullary Fixation Rods Due to Sealer Calibration
Zimmer Manufacturing B.V. is recalling 1,394 sterile intramedullary fixation rods and reconstruction screws due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.
Product
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…
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ModerateFDA (Devices)··2016-03-23
Zimmer Manufacturing Recalls 34 Sterile Bone Fixation Screws
Zimmer Manufacturing B.V. is recalling 34 sterile bone fixation screws due to insufficient sealer calibration data. The affected units were packaged between August 2010 and April 2013.
Product
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…
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