BEUDAMED
    FDA Recall Terminated

    Crossfire Acetabular II Insert. Catalog No: 2041C-2642.

    Recall: Z-0560-04 · Initiated January 9, 2004

    Recall

    Recall Number
    Z-0560-04
    Event Number
    28181
    Firm
    Stryker Howmedica Osteonics
    FEI Number
    3003070421
    Product Code
    JDL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 9, 2004
    Posted
    July 20, 2004
    Terminated
    March 8, 2004
    Address
    300 Commerce Ct, Mahwah, NJ, 07430-2104

    Description

    Crossfire Acetabular II Insert. Catalog No: 2041C-2642.

    Reason

    This device is not approved for sale in the US.

    Action

    Letters dated 1/9/2004 and 1/12/2004 were sent to Surgical Resources and Dr. Vorenkamp alerting them to the situation.

    Distribution

    The one device was shipped to Surgical Resources, 1150 Torrey Road, Suite A, Fenton, MI 48430 for Dr. Steven E. Vorenkamp, M.D., Petoskey, MI..

    Quantity

    3 (1 unit in US)