BEUDAMED
    FDA Recall Terminated

    Rejuvenate Broach Catalog No: 1601-1005, 1601-1006, 1601-1007, 1601-1008, 1601-1009, 1601-1010 Stryker Orthopaedics, Mahwah, NJ. 07430 Contours the proximal femur to the geometry of the stem to provide a complimentary fit of the stem to the bone.The broaches are designed with a series of teeth that are intended to seat against highly densified cancellous bone for the interference press-fit in the uncemented application.

    Recall: Z-2349-2008 · Initiated January 25, 2008

    Recall

    Recall Number
    Z-2349-2008
    Event Number
    49087
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    HTQ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 25, 2008
    Posted
    September 19, 2008
    Terminated
    September 22, 2008
    Address
    325 Corporate Dr, Mahwah, NJ, 07430-2002

    Description

    Rejuvenate Broach Catalog No: 1601-1005, 1601-1006, 1601-1007, 1601-1008, 1601-1009, 1601-1010 Stryker Orthopaedics, Mahwah, NJ. 07430 Contours the proximal femur to the geometry of the stem to provide a complimentary fit of the stem to the bone.The broaches are designed with a series of teeth that are intended to seat against highly densified cancellous bone for the interference press-fit in the uncemented application.

    Reason

    Rejuvenate Broach system was designed in a manner that may result in the potential for a medical calcar fracture.

    Action

    Stryker notified all branches and agencies to return the product on January 25, 2008. A formal recall letter was not written as all product was in their control.

    Distribution

    Nationwide Distribution.

    Quantity

    78 devices