BEUDAMED
    FDA Enforcement Class II Terminated

    GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100

    Recall: Z-0490-2022 · Reported January 19, 2022

    Enforcement

    Recall Number
    Z-0490-2022
    Event ID
    89240
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    DePuy Orthopaedics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    January 19, 2022
    Initiation Date
    December 7, 2021
    Classification Date
    January 11, 2022
    Termination Date
    May 17, 2024
    Address
    700 Orthopaedic Dr, N/A, Warsaw, IN, 46582-3994, United States

    Description

    GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100

    Reason

    Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage

    Code Info

    Lot #: 9793946, 9793947, 9802315, 9802316, 9802317, 9802318, 9802320, 9813856, 9814516, 9824502, 9824503, 9824505, 9834401, 9834402, 9836078, 9841198, 9880972, 9886688, 9887451, 9887452 GTIN: 10603295004189

    Distribution

    Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, Denmark, Estonia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Netherlands, New Zealand, Norway, Poland, South Africa, Sweden, Switzerland, Thailand, United Kingdom.

    Quantity

    140 units