BEUDAMED
    FDA Enforcement Class I 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 · Reported April 24, 2013

    Enforcement

    Recall Number
    Z-1052-2013
    Event ID
    64308
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Howmedica Osteonics Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 24, 2013
    Initiation Date
    November 8, 2012
    Classification Date
    April 12, 2013
    Termination Date
    January 11, 2021
    Address
    325 Corporate Drive, N/A, Mahwah, NJ, 07430, United States

    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.

    Code Info

    Catalog No: TR7100-L and TR7100-R Lot Code: All

    Distribution

    USA Nationwide Distribution

    Quantity

    7868 units