BEUDAMED
    FDA Enforcement Class II Terminated

    Triathlon Prim CEM FXD BPLT 7, Catalog No. 5520B700

    Recall: Z-2329-2021 · Reported August 25, 2021

    Enforcement

    Recall Number
    Z-2329-2021
    Event ID
    88422
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Howmedica Osteonics Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 25, 2021
    Initiation Date
    July 1, 2021
    Classification Date
    August 19, 2021
    Termination Date
    May 17, 2023
    Address
    325 Corporate Dr, N/A, Mahwah, NJ, 07430-2006, United States

    Description

    Triathlon Prim CEM FXD BPLT 7, Catalog No. 5520B700

    Reason

    The internal profile of the Triathlon Prim (Baseplate) is potentially oversized; there may be a witness mark (taper) at the bottom of the internal profile of the baseplate, which prevents the insert from locking on the baseplate.

    Code Info

    Lot JHS2H

    Distribution

    Worldwide distribution - US Nationwide distribution in the states AR, CO, MN, MS, NJ, OK, PA, TX and the countries of China and Italy.

    Quantity

    14 US; 2 OUS