BEUDAMED
    FDA Recall Terminated

    Avenir Muller Stem; Item Number: 01.06010.104, Lot Number: 2905496, UDI: (01)00889024479500 (17)220430 (10)2905496

    Recall: Z-1525-2018 · Initiated February 28, 2018

    Recall

    Recall Number
    Z-1525-2018
    Event Number
    79677
    Firm
    Zimmer GmbH Sulzerallee 8 Winterthur Switzerland
    FEI Number
    3005233524
    Product Code
    LZO
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    February 28, 2018
    Terminated
    October 25, 2019

    Description

    Avenir Muller Stem; Item Number: 01.06010.104, Lot Number: 2905496, UDI: (01)00889024479500 (17)220430 (10)2905496

    Reason

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

    Action

    On March 7, 2018 Field Safety Corrective Action Notices were hand delivered by Zimmer Biomet team members or their representatives. Customers were instructed to complete the following: 1.Review this notification for awareness of the contents. 2.Assist your Zimmer Biomet sales representative to quarantine immediately all affected implants. 3.Your Zimmer Biomet sales representative will remove the affected implants from your facility. 4.Complete Attachment 1 Certificate of Acknowledgement. a. Return a digital copy to [email protected]. b. Retain a copy of the Certificate of Acknowledgement with your field action records in the event of a compliance audit of your documentation. 5.If after reviewing the notice you have further questions or concerns please contact your Zimmer Biomet representative.

    Distribution

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