BEUDAMED
    FDA Recall Terminated

    Hoffman II compact Sterile Wrist Kit is used in the stabilization of open and unstable fractures.

    Recall: Z-2080-2008 · Initiated August 17, 2005

    Recall

    Recall Number
    Z-2080-2008
    Event Number
    48204
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    JEC
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 17, 2005
    Posted
    September 16, 2008
    Terminated
    September 24, 2008
    Address
    325 Corporate Dr, Mahwah, NJ, 07430-2002

    Description

    Hoffman II compact Sterile Wrist Kit is used in the stabilization of open and unstable fractures.

    Reason

    Stryker Orthopaedics became aware that the pin of the Hoffmann II Compact External Fixation System may jam into the Soft Tissue protector.

    Action

    Letters were sent to Stryker branches and hospitals on August 17, 2005. If you have questions concerning this recall, contact Rita Intorrella at 201-831-5825 or Katherine Collins at 201-831-5025.

    Distribution

    The product was distributed to 23 Stryker Branches, 25 hospitals and 1 government hospital nationwide

    Quantity

    105 units