BEUDAMED
    FDA Recall Terminated

    Stryker Navigation System - Hip Module Patient Tracker, green; Model 6007-005-000.

    Recall: Z-0020-05 · Initiated July 14, 2004

    Recall

    Recall Number
    Z-0020-05
    Event Number
    29675
    Firm
    Stryker Instruments, Instruments Div.
    FEI Number
    1811755
    Product Code
    HAW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 14, 2004
    Posted
    October 19, 2004
    Terminated
    October 18, 2004
    Address
    4100 E. Milham, Kalamazoo, MI, 49001

    Description

    Stryker Navigation System - Hip Module Patient Tracker, green; Model 6007-005-000.

    Reason

    The tracker is not locking adequately to the anchoring pin, resulting in unacceptable movement, which will affected the patient tracker system.

    Action

    Sales force was notified these pre-launch devices are not to be used for surgical use via e-mail and telephone calls on 7/14/04.

    Distribution

    United States.