BEUDAMED
    FDA Recall Terminated

    ShapeMatch Cutting Guides Product Usage: The ShapeMatch Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee arthroplasty components intraoperatively and in guiding the marking of bone before cutting.

    Recall: Z-1052-2013 · Initiated November 8, 2012

    Recall

    Recall Number
    Z-1052-2013
    Event Number
    64308
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    MBH
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 8, 2012
    Posted
    April 12, 2013
    Terminated
    January 11, 2021
    Address
    325 Corporate Drive, Mahwah, NJ, 07430

    Description

    ShapeMatch Cutting Guides Product Usage: The ShapeMatch Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee arthroplasty components intraoperatively and in guiding the marking of bone before cutting.

    Reason

    With regards to ShapeMatch Cutting Guides using MRI Imaging, Stryker Orthopaedics has become aware that there are potential issues associated with internal processes for planning cases and producing ShapeMatch Cutting Guides.

    Action

    Stryker sent Product Correction Bulletins on 11/8/2012 dated 11/9/2012 and 11/19/2012 to all affected customers. Stryker sent an updated Urgent Medical Device Product Notification letters and Acknowledgement letters dated 1/24/2013 through 1/28/2013 to all affected customers via Fed Ex with return receipt: The letter identified the affect product, problem, potential hazards, risk mitigating factors and actions to be taken. For questions call 201-831-6878. Stryker issued press release on 4/10/2013.

    Distribution

    USA Nationwide Distribution

    Quantity

    7868 units