The Recall Desk

FDA (Devices) recall action 79095

Zimmer Biomet, Inc. recalled 2 products on 2018-02-21

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2018-02-21
Critical
0
Units
39

Why these products were recalled

The affected AGC 2000 LP Patella products were over-molded leaving the outside diameter nonconforming to the print dimension.

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

1–2 of 2

  • HighFDA (Devices)··2018-02-21

    Zimmer Biomet Recalls AGC 2000 LP Patella Knee Implants

    Zimmer Biomet is recalling 11 AGC 2000 LP Patella knee implants because they were over-molded, causing the outside diameter to not match the required specifications.

    Product
    AGC 2000 LP Patella, labeled as AGC Porous Patellar Med, Model Number 150804. Product Usage: For use in Total Knee Arthroplasty.
    Category
    Distribution
    4 states
  • HighFDA (Devices)··2018-02-21

    Zimmer Biomet Recalls AGC 2000 LP Patella Knee Implant Devices

    Zimmer Biomet is recalling 28 AGC 2000 LP Patella knee implants because they were over-molded, leaving the outside diameter nonconforming to the print dimension.

    Product
    AGC 2000 LP Patella, labeled as AGC Porous Patellar SM, Model Number 150802. Product Usage: For use in Total Knee Arthroplasty.
    Category
    Distribution
    4 states