The Recall Desk

FDA (Devices) recall action 63124

Zimmer, Inc. recalled 3 products on 2012-10-24

The FDA (Devices) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2012-10-24
Critical
0
Units
138

Why these products were recalled

Zimmer Inc. is initiating a removal of the CPT Modular Stem (item 00-8011-001-00), CPT Stem Petite (item 00-8011-000-05; ) and CPT Femoral Stem 12/14 Neck Taper Extended Offset,(item 00-8114-001-10 ) because devices were packaged in incorrect cartons and distributed internationally and domestically. Zimmer received five complaints of this packaging issue.

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.

States named across these recalls

1–3 of 3

  • ModerateFDA (Devices)··2012-10-24

    Zimmer Recalls CPT Modular Hip Stems Due to Packaging Errors

    Zimmer Inc. is removing CPT Modular Hip Stems from the market because they were packaged in incorrect cartons and distributed internationally and domestically.

    Product
    CPT Modular Stem, Item No. 00-8011-001-00; Lot 61947708. CPT stems are primary cemented femoral hip stems used by surgeons in total hip arthroplasty.
    Category
    Distribution
    2 states
  • ModerateFDA (Devices)··2012-10-24

    Zimmer Recalls CPT Hip Stems Due to Incorrect Packaging Cartons

    Zimmer Inc. is removing CPT hip stems from the market because they were packaged in incorrect cartons and distributed domestically and internationally.

    Product
    CPT Femoral Stem 12/14 Neck Taper Extended Offset,(item 00-8114-001-10. CPT stems are primary cemented femoral hip stems used by surgeons in total hip arthroplasty.
    Category
    Distribution
    2 states
  • ModerateFDA (Devices)··2012-10-24

    Zimmer Recalls CPT Hip Stems Due to Incorrect Packaging

    Zimmer, Inc. is removing CPT Hip System femoral stems from the market because they were packaged in incorrect cartons and distributed internationally and domestically.

    Product
    CPT Hip System Femoral Stem Petite, Item No. 00-8011-000-05. CPT stems are primary cemented femoral hip stems used by surgeons in total hip arthroplasty.
    Category
    Distribution
    2 states