BEUDAMED
    FDA Recall Terminated

    Stryker Orthopaedics Restoration Gap Plate Screw; Dia. 6.5 mm, Lnth 30 mm; Made in USA, Sterile; Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430

    Recall: Z-2137-2009 · Initiated June 26, 2009

    Recall

    Recall Number
    Z-2137-2009
    Event Number
    52713
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    MEH
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    June 26, 2009
    Posted
    September 14, 2009
    Terminated
    July 27, 2010
    Address
    325 Corporate Drive, Mahwah, NJ, 07430

    Description

    Stryker Orthopaedics Restoration Gap Plate Screw; Dia. 6.5 mm, Lnth 30 mm; Made in USA, Sterile; Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430

    Reason

    Raw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.

    Action

    Stryker Orthopaedics issued "Urgent Product Recall" letters via Federal Express priority overnight beginning June 26, 2009 to Branches, Hospital Risk Management and Chief of Orthopaedics and Surgeons. All users are requested to examine their inventory, retrieve all affected product and return for reconciliation to Stryker Orthopaedics. Users are also requested to complete the enclosed Product Accountability Form and fax with necessary information to the firm at 1-201-831-6069. For further information, contact Stryker Orthopaedics at 1-201-831-5970.

    Distribution

    Worldwide Distribution

    Quantity

    51,113 total - all sizes.