The Recall Desk

FDA (Devices) recall action 68818

Zimmer, Inc. recalled 7 products on 2014-09-03

The FDA (Devices) publishes a recall like this one as 7 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 7 pages.

Products
7
Announced
2014-09-03
Critical
0
Units
6,804,875

Why these products were recalled

Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple test samples from each of the six configurations failed simulated distribution and shipping testing when the devices either breached inner or outer package trays or seal integrity was lost.

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.

1–7 of 7

  • ModerateFDA (Devices)··2014-09-03

    Zimmer Recalls Trauma Large Screws Due to Packaging Design Failures

    Zimmer, Inc. is recalling 972,125 units of sterile-packaged Trauma Large Screws because packaging design verification tests failed, resulting in compromised seal integrity.

    Product
    Trauma Large Screws: CANN BONE SCREW 7.0MMX100MMLG CANN BONE SCREW 7.0X105LG CANN BONE SCREW 7.0X105LG CANN BONE SCREW 7.0MMX105MMLG CANN BONE SCREW 7.0X110LG CANN BONE SCREW 7.0X110LG CANN BONE SCREW 7.0MMX110MMLG CANN BONE SCREW 7.0X115LG CANN BONE SCREW 7.0X115LG…
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    0 states
  • HighFDA (Devices)··2014-09-03

    Zimmer Recalls Moore & Thompson Hip Stems Due to Packaging Failures

    Zimmer, Inc. is recalling Moore & Thompson Hip Stems because packaging design verification tests failed, resulting in compromised seal integrity or breached trays.

    Product
    Moore & Thompson Hip Stems: FNSTRD HIP 38HDX127ST FNSTRD HIP 40HDX127ST FNSTRD HIP 41HDX127ST FNSTRD HIP 42HDX127ST FNSTRD HIP 43HDX127ST FNSTRD HIP 44HDX127ST FNSTRD HIP 45HDX140ST FNSTRD HIP 46HDX140ST FNSTRD HIP 47HDX140ST FNSTRD HIP 48HDX140ST FNSTRD HIP…
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    0 states
  • ModerateFDA (Devices)··2014-09-03

    Zimmer Recalls Knee Stem Extensions Due to Packaging Design Failures

    Zimmer, Inc. is recalling specific knee stem extensions and impactor sleeves because packaging design verification tests failed, potentially compromising device sterility.

    Product
    Knee Stem Extensions & Impactor Sleeve: STEM IMPLANT 20MMDX145MM STEM IMPLANT 22MMDX145MM STEM IMPLANT 24MMDX145MM SHARP FLUTED ST 20MMDX75MM SHARP FLUTED ST 22MMDX75MM SHARP FLTD ST 24MMDX75MM SHARP FLUTED ST 20MMDX130MM SHARP FLUTED ST 22MMDX130MM SHARP FLUTED ST…
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    0 states
  • ModerateFDA (Devices)··2014-09-03

    Zimmer Recalls Trauma Tubes and Plates Due to Packaging Failures

    Zimmer, Inc. is recalling specific trauma tubes and plates because packaging design verification tests failed, resulting in compromised seal integrity.

    Product
    Trauma Tubes and Plates: TUBE & SCP PLT 90DX150LG TUBE & SCP PLT 90DX205LG TUBE & SCP PLT 90DX255LG TUBE & SCP PLT 95DX150LG TUBE & SCP PLT 95DX205LG TUBE & SCP PLT 95DX255LG TUBE&SCP PLT 130DX8H TUBE&SCP PLT 130DX10H TUBE&SCP PLT 130DX12H TUBE&SCP PLT 130DX14H…
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    0 states
  • ModerateFDA (Devices)··2014-09-03

    Zimmer Recalls Endo and Unipolar Femoral Heads Due to Packaging Failures

    Zimmer, Inc. is recalling 972,125 units of Endo and Unipolar Femoral Heads because packaging design verification tests failed, potentially compromising sterility.

    Product
    Endo & Unipolar Femoral Heads: ENDO FEMORAL HEAD 43MM DIA, ENDO FEMORAL HEAD 53MM DIA, ENDO FEMORAL HEAD 47MM DIA, ENDO FEMORAL HEAD 50MM DIA, ENDO FEMORAL HEAD 42MM DIA, ENDO FEMORAL HEAD 54MM DIA, ENDO FEMORAL HEAD 48MM DIA, ENDO FEMORAL HEAD 41MM DIA, ENDO FEMORAL HEAD 42MM…
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    0 states
  • ModerateFDA (Devices)··2014-09-03

    Zimmer Recalls Knee Instrument Fixation Screws Due to Packaging Failures

    Zimmer, Inc. is recalling 972,125 units of knee fixation screws worldwide because packaging design verification tests failed, potentially compromising sterility.

    Product
    Knee Instrument Fixation Screws: 48MM HEADED SCREW 48MM HEADLESS SCREW MIS HEADED SCREW, 48MM MIS HEADLESS SCREW, 48MM
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    0 states
  • ModerateFDA (Devices)··2014-09-03

    Zimmer Recalls Endo and Unipolar Femoral Heads Due to Packaging Failures

    Zimmer, Inc. is recalling 972,125 units of Endo and Unipolar Femoral Heads because packaging design verification tests failed, potentially compromising sterility.

    Product
    Endo & Unipolar Femoral Heads: ENDO FEMORAL HEAD 41MM DIA ENDO FEMORAL HEAD 42MM DIA ENDO FEMORAL HEAD 43MM DIA ENDO FEMORAL HEAD 44MM DIA ENDO FEMORAL HEAD 45MM DIA ENDO FEMORAL HEAD 46MM DIA ENDO FEMORAL HEAD 47MM DIA ENDO FEMORAL HEAD 48MM DIA ENDO FEMORAL HEAD 49MM…
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    0 states