The Recall Desk

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 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…
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    0 states
  • ModerateFDA (Devices)··2016-03-23

    Zimmer Manufacturing Recalls Hip Arthroplasty Femoral Heads Due to Sealer Calibration

    Zimmer Manufacturing B.V. is recalling 366 units of 6 Degree COCR Femoral Heads used in hip arthroplasty due to insufficient sealer calibration data.

    Product
    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…
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    0 states
  • 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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    0 states
  • 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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    0 states
  • HighFDA (Devices)··2016-03-23

    Zimmer Free-Lock Tube and SCP Plate Recall for Sterility Concerns

    Zimmer Manufacturing B.V. is recalling 285 units of Free-Lock Tube & SCP Plate devices due to insufficient sealer calibration data affecting sterility.

    Product
    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…
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    0 states
  • 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…
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    0 states
  • ModerateFDA (Devices)··2016-03-23

    Zimmer Manufacturing Recalls Sterile Bone Fixation Appliances Due to Calibration Issues

    Zimmer Manufacturing B.V. is recalling 1,209 units of sterile metallic bone fixation appliances due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    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…
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    0 states
  • 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…
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    0 states
  • ModerateFDA (Devices)··2016-03-23

    Zimmer Manufacturing Recalls Sterile Bone Fixation Screws Due to Sealer Calibration

    Zimmer Manufacturing B.V. is recalling specific lots of sterile 4.5 x 26 Cortical Screws due to insufficient sealer calibration data during packaging.

    Product
    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…
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    0 states
  • ModerateFDA (Devices)··2016-03-23

    Zimmer Manufacturing Recalls Sterile Orthopedic Screws Due to Calibration Data Issues

    Zimmer Manufacturing B.V. is recalling 4,335 sterile orthopedic screws and bone staples due to insufficient sealer calibration data.

    Product
    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…
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    0 states
  • 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…
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    0 states
  • ModerateFDA (Devices)··2016-03-23

    Zimmer Manufacturing Recalls Interlocking Intramedullary Screws Due to Sealer Calibration Issues

    Zimmer Manufacturing B.V. is recalling 4,752 sterile interlocking intramedullary screws due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    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…
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    0 states
  • ModerateFDA (Devices)··2016-03-23

    Zimmer Versys Heritage Femoral Stem Recall Due to Sealer Calibration

    Zimmer Manufacturing B.V. is recalling 360 units of Versys Heritage Femoral Stems due to insufficient sealer calibration data. The affected sterile products were packaged between August 2010 and April 2013.

    Product
    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…
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    0 states
  • ModerateFDA (Devices)··2016-03-23

    Zimmer Manufacturing Recalls Sterile Polyethylene Patches Due to Calibration Issues

    Zimmer Manufacturing B.V. is recalling sterile polyethylene patches due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    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…
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    0 states
  • HighFDA (Devices)··2016-03-23

    Zimmer Manufacturing Recalls 6 Degree COCR Femoral Heads for Sterility Concerns

    Zimmer Manufacturing B.V. is recalling 209 units of 6 Degree COCR Femoral Heads due to insufficient sealer calibration data. The affected sterile products were distributed nationwide in the US.

    Product
    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…
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    0 states
  • ModerateFDA (Devices)··2016-03-23

    Zimmer Modular Hip Cups Recalled for Insufficient Sealer Calibration Data

    Zimmer Manufacturing B.V. is recalling sterile modular hip cups due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    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…
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    0 states
  • HighFDA (Devices)··2016-03-23

    Zimmer Manufacturing Recalls Sterile Bone Fixation Screws Due to Sealer Calibration

    Zimmer Manufacturing B.V. is recalling 56 sterile bone fixation screws due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    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…
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  • HighFDA (Devices)··2016-03-23

    Zimmer Versa-FX II Keyless Bone Fixation Devices Recalled for Sterility Concerns

    Zimmer Manufacturing B.V. is recalling 5,538 units of Versa-FX II Keyless bone fixation devices due to insufficient sealer calibration data affecting sterility.

    Product
    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…
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    0 states
  • ModerateFDA (Devices)··2016-03-23

    Zimmer Herbert Bone Screws Recalled for Insufficient Sealer Calibration Data

    Zimmer Manufacturing B.V. is recalling 4,018 units of Herbert bone screws due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    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…
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    0 states
  • ModerateFDA (Devices)··2016-03-23

    Zimmer HGP II Acetabular Cup Recall Due to Sealer Calibration

    Zimmer Manufacturing B.V. is recalling 2,236 HGP II Acetabular Cup components due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    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…
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    0 states
  • ModerateFDA (Devices)··2016-03-23

    Zimmer Manufacturing Recalls Hip Stems Due to Insufficient Sealer Calibration Data

    Zimmer Manufacturing B.V. is recalling specific hip stem products because of insufficient sealer calibration data for items packaged in Building II between August 2010 and April 2013.

    Product
    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…
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    0 states
  • ModerateFDA (Devices)··2016-03-23

    Zimmer Manufacturing Recalls Sterile Bone Fixation Screws Due to Calibration Issues

    Zimmer Manufacturing B.V. is recalling 12 sterile bone fixation screws due to insufficient sealer calibration data. The products were distributed nationwide in the US.

    Product
    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…
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    0 states
  • ModerateFDA (Devices)··2016-03-23

    Zimmer Manufacturing Recalls Anti-Rotation Screws Due to Sealer Calibration Issues

    Zimmer Manufacturing B.V. is recalling seven ITST Anti-Rotation Screws because of insufficient sealer calibration data. The affected sterile products were distributed nationwide in the US.

    Product
    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…
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    0 states
  • HighFDA (Devices)··2016-03-23

    Zimmer Manufacturing Recalls Free-Lock Lag Screws Due to Sterility Concerns

    Zimmer Manufacturing B.V. is recalling 3,500 units of Free-Lock Lag Screws and related bone fixation products due to insufficient sealer calibration data affecting sterility.

    Product
    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…
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    0 states
  • HighFDA (Devices)··2016-03-23

    Zimmer Versis Press Fit Hip Components Recalled for Sterility Concerns

    Zimmer Manufacturing B.V. is recalling 2,388 Versis Press Fit hip arthroplasty components due to insufficient sealer calibration data, raising concerns about the sterility of the devices.

    Product
    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…
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