BEUDAMED
    FDA Enforcement Class II Terminated

    M/DN Intramedullary Fixation Humeral Guide Wire - Smooth 2.4 mm Diameter 70 cm Length Single Use Only; Item Number: 00-2255-025-00

    Recall: Z-1465-2018 · Reported May 2, 2018

    Enforcement

    Recall Number
    Z-1465-2018
    Event ID
    79681
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 2, 2018
    Initiation Date
    March 26, 2018
    Classification Date
    April 20, 2018
    Termination Date
    November 18, 2020
    Address
    1800 W Center St, N/A, Warsaw, IN, 46580-2304, United States

    Description

    M/DN Intramedullary Fixation Humeral Guide Wire - Smooth 2.4 mm Diameter 70 cm Length Single Use Only; Item Number: 00-2255-025-00

    Reason

    Potential failure of sterile packaging seal.

    Code Info

    Lot Numbers: 63733049 63738623 63748399 63753770 63758430 63849380 77006555 77006556 77006557

    Distribution

    US Nationwide and the following countries: Brazil, Singapore, Canada, Australia, Japan, Malaysia, Chile, Netherlands, Trinidad

    Quantity

    19483 total products