BEUDAMED
    FDA Recall Terminated

    Gammas Set Screwdriver Instrument Set, Basic Stryker Trauma GmbH, Germany; Distributed by Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 - Orthopedic Device. The Gamma3 Locking Nail Systems are intramedullary short and long fixation nails intended for control of rotation and shortening of fractured femurs. The screwdriver is used to place the set screw in the nail.

    Recall: Z-1627-2008 · Initiated February 22, 2008

    Recall

    Recall Number
    Z-1627-2008
    Event Number
    46963
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    HXX
    Status
    Terminated
    Root Cause
    Finished device change control
    Initiated
    February 22, 2008
    Posted
    September 16, 2008
    Terminated
    October 25, 2010
    Address
    325 Corporate Dr, Mahwah, NJ, 07430-2002

    Description

    Gammas Set Screwdriver Instrument Set, Basic Stryker Trauma GmbH, Germany; Distributed by Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 - Orthopedic Device. The Gamma3 Locking Nail Systems are intramedullary short and long fixation nails intended for control of rotation and shortening of fractured femurs. The screwdriver is used to place the set screw in the nail.

    Reason

    Stryker Trauma has become aware that five lots of the Gamma3 Set Screwdriver have hexagon tips that were not hardened to specification.

    Action

    On February 22, 2008 Urgent Product Recall notification letters were sent to Stryker Branches/Agencies, Risk Management Departments at hospitals and surgeons via Federal Express. If you have any questions contact Rita Intorrella at (201) 831-5825 or the Hip Fracture Team at (201) 831-5291.

    Distribution

    Class II Recall - Nationwide Distribution.

    Quantity

    43 total (single and kits)