BEUDAMED
    FDA Enforcement Class II Ongoing

    TRIDENTII HEMI CLUSTER48D-indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-48D

    Recall: Z-1622-2024 · Reported May 1, 2024

    Enforcement

    Recall Number
    Z-1622-2024
    Event ID
    94215
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Howmedica Osteonics Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 1, 2024
    Initiation Date
    February 27, 2024
    Classification Date
    April 25, 2024
    Address
    325 Corporate Dr, N/A, Mahwah, NJ, 07430-2006, United States

    Description

    TRIDENTII HEMI CLUSTER48D-indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-48D

    Reason

    The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell

    Code Info

    UDI-DI: (01)07613327380903(17)290313(10) Lot Number: 14875651 15005253 16044255

    Distribution

    Nationwide Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UK

    Quantity

    45 units