The Recall Desk

FDA (Devices) recall action 79161

Zimmer Biomet, Inc. recalled 2 products on 2018-02-28

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
2018-02-28
Critical
0
Units
48

Why these products were recalled

Knee implant components (tibial bearings) are labeled with the incorrect size.

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

  • ModerateFDA (Devices)··2018-02-28

    Zimmer Biomet Recalls Vanguard Knee Implant Components Due to Labeling Error

    Zimmer Biomet is recalling 24 Vanguard Complete Knee System tibial bearings because they are labeled with the incorrect size. The components are intended for use in total knee arthroplasty.

    Product
    Vanguard Complete Knee System, Vanguard CR Tibial Bearing 12x71/75, Item Number: 183442 Product Usage: For use in total knee arthroplasty
    Category
    Distribution
    12 states
  • ModerateFDA (Devices)··2018-02-28

    Zimmer Biomet Recalls Vanguard Knee Implant Components Due to Labeling Error

    Zimmer Biomet is recalling 24 Vanguard Complete Knee System tibial bearings because they are labeled with the incorrect size.

    Product
    Vanguard Complete Knee System, Vanguard CR Lipped Tibial Bearing 10x71/75, Item Number: 183540 Product Usage: For use in total knee arthroplasty
    Category
    Distribution
    12 states