BEUDAMED
    FDA Recall Terminated

    Offset Adaptor Trial - 2MM, Triathlon Revision Instruments. Non-Sterile; Howmedica Osteonics Corp: 325 Corporate Drive, Mahwah, NJ 07430. Indications for use include disabling joint disease of the knee.

    Recall: Z-1607-2009 · Initiated April 16, 2009

    Recall

    Recall Number
    Z-1607-2009
    Event Number
    52072
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 16, 2009
    Posted
    July 23, 2009
    Terminated
    April 5, 2010
    Address
    325 Corporate Dr, Mahwah, NJ, 07430

    Description

    Offset Adaptor Trial - 2MM, Triathlon Revision Instruments. Non-Sterile; Howmedica Osteonics Corp: 325 Corporate Drive, Mahwah, NJ 07430. Indications for use include disabling joint disease of the knee.

    Reason

    Triathlon Offset Adaptors may seize during surgery and the OR staff may be unable to disassemble the instrument using the removal tool.

    Action

    "Urgent Product Correction" letters dated April 16, 2009 were sent to all Stryker Representatives, Hospital Rick Management Departments, Hospital Chief of Orthopaedics, Surgeon and countries by Federal Express. The notice explains the Issue, Potential Hazards and Risk Mitigation Factors of the affected product(s) including a request to complete and return the Product Correction Form. For further questions, contact Stryker Orthopedics, Division of Regulatory Reporting at 201-831-5970.

    Distribution

    Worldwide Distribution.

    Quantity

    2498 units total, all sizes.