The Recall Desk

FDA (Devices) recall action 79677

Zimmer GmbH recalled 2 products on 2018-05-02

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
2018-05-02
Critical
0
Units
—

Why these products were recalled

A potential commingle that could result in the product in the package not matching the product on the outer label.

The agency’s own wording, quoted from the enforcement report.

1–2 of 2

  • ModerateFDA (Devices)··2018-05-02

    Zimmer GmbH Recalls Avenir Muller Stem Due to Potential Label Mismatch

    Zimmer GmbH is recalling specific Avenir Muller Stem implants because a potential commingle may cause the product in the package to not match the outer label.

    Product
    Avenir Muller Stem; Item Number: 01.06010.003, Lot Number: 2904368, UDI: (01) 00889024479494 (17) 220331 (10) 2904368
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2018-05-02

    Zimmer GmbH Recalls Avenir Muller Stem Due to Potential Label Mismatch

    Zimmer GmbH is recalling Avenir Muller Stems due to a potential commingle that could result in the product not matching the outer label.

    Product
    Avenir Muller Stem; Item Number: 01.06010.104, Lot Number: 2905496, UDI: (01)00889024479500 (17)220430 (10)2905496
    Category
    Distribution
    0 states