BEUDAMED
    FDA Enforcement Class II Terminated

    Avenir Muller Stem; Item Number: 01.06010.003, Lot Number: 2904368, UDI: (01) 00889024479494 (17) 220331 (10) 2904368

    Recall: Z-1524-2018 · Reported May 2, 2018

    Enforcement

    Recall Number
    Z-1524-2018
    Event ID
    79677
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer GmbH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 2, 2018
    Initiation Date
    February 28, 2018
    Classification Date
    April 26, 2018
    Termination Date
    October 25, 2019
    Address
    Sulzerallee 8, N/A, Winterthur, N/A, N/A, Switzerland

    Description

    Avenir Muller Stem; Item Number: 01.06010.003, Lot Number: 2904368, UDI: (01) 00889024479494 (17) 220331 (10) 2904368

    Reason

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

    Code Info

    Lot Number: 2904368

    Distribution

    There was no distribution to the US. The distribution occurred to the following countries: Belgium, Switzerland, Germany, France, Canary Islands, Italy, and Thailand.

    Quantity

    N/A