BEUDAMED
    FDA Recall Terminated

    Triathlon Baseplate Impactor Extractor, Orthopedic manual surgical instrument, Catalog Number 6541-4-805, Non-Sterile, Stryker Howmedica Osteonics Corp, Mahwah, NJ 07430

    Recall: Z-1105-2008 · Initiated February 23, 2005

    Recall

    Recall Number
    Z-1105-2008
    Event Number
    46331
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    HWA
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 23, 2005
    Posted
    May 14, 2008
    Terminated
    May 30, 2008
    Address
    325 Corporate Dr, Mahwah, NJ, 07430-2002

    Description

    Triathlon Baseplate Impactor Extractor, Orthopedic manual surgical instrument, Catalog Number 6541-4-805, Non-Sterile, Stryker Howmedica Osteonics Corp, Mahwah, NJ 07430

    Reason

    Insertion/Removal Difficulties: The Baseplate Impactor/Extractor may not assemble/disassemble easily to the baseplate.

    Action

    Consignees were notified via an Important Market Withdrawal Letter sent 2/25/05. The letter instructed users to fax a Product Accountability Form to the recalling firm identifying any affected products and to return them to the firm. The letter informed users that the products will be reworked and returned at a later date. The letter also identified other products that could be used as replacements. For additional information, contact 201-831-5825 or 201-831-5110.

    Distribution

    Worldwide Distribution

    Quantity

    293 total units