BEUDAMED
    FDA Recall Terminated

    Stryker, Gamma3, The Compact Version of the Gamma Nail System, Operative Technique for Hip Fracture System, Trochanteric and Long Nails.

    Recall: Z-1351-2009 · Initiated March 2, 2009

    Recall

    Recall Number
    Z-1351-2009
    Event Number
    51409
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    JDS
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    March 2, 2009
    Posted
    June 1, 2009
    Terminated
    August 17, 2012
    Address
    325 Corporate Dr, Mahwah, NJ, 07430

    Description

    Stryker, Gamma3, The Compact Version of the Gamma Nail System, Operative Technique for Hip Fracture System, Trochanteric and Long Nails.

    Reason

    Operative Technique: further clarification and guidance is needed to help reduce the potential for distal mis-drilling of the short Gamma3 Trochanteric Nails.

    Action

    Stryker sent Urgent Product Recall letters by Federal Express on March 2, 2009 to Stryker Branches, Chief of Orthopaedics, Hospital Risk Management and Surgeons. Letters were sent to all who have used the Gamma3 products in the past.

    Distribution

    Nationwide.

    Quantity

    18232