BEUDAMED
    FDA Recall Terminated

    Stryker Ortholock, Stryker, Kalamazoo, MI; Part 6007-003-000. Stryker Ortholock is used to firmly anchor a tracker intended for patient tracking during computer aided orthopaedic and trauma applications.

    Recall: Z-2294-2008 · Initiated June 5, 2008

    Recall

    Recall Number
    Z-2294-2008
    Event Number
    48710
    Firm
    Stryker Instruments Div. of Stryker Corporation
    FEI Number
    1811755
    Product Code
    HAW
    Status
    Terminated
    Root Cause
    Labeling False and Misleading
    Initiated
    June 5, 2008
    Posted
    September 16, 2008
    Terminated
    December 1, 2009
    Address
    4100 E. Milham Ave., Portage, MI, 49002-9704

    Description

    Stryker Ortholock, Stryker, Kalamazoo, MI; Part 6007-003-000. Stryker Ortholock is used to firmly anchor a tracker intended for patient tracking during computer aided orthopaedic and trauma applications.

    Reason

    Instructions have been updated to include new warnings regarding percutaneous pin placement during surgery in order to mitigate the risk of femur fractures.

    Action

    Consignees were notified via letter dated 6/5/08 providing them with additional warnings and instructions for use for these products. Contact Stryker Customer Service at 1-800-800-4236, ext. 3808.

    Distribution

    Nationwide, Austria, Australia, Brazil, Canada, China, Dubai, England, France, Germany, Hong Kong, India, Italy, Japan, Malaysia, Netherlands, New Zealand, Poland, Singapore, South Africa, South Korea, Sweden, Switzerland and Taiwan.

    Quantity

    28,861 boxes of all products.