BEUDAMED
    FDA Recall Terminated

    Stryker Modular Replacement System Curved Cemented Stem; MRS 12mmx203 Femoral Stem. Catalog Number: 6485-3-313; Stryker Orthopaedics Mahwah, NJ 07430

    Recall: Z-0921-2008 · Initiated November 15, 2007

    Recall

    Recall Number
    Z-0921-2008
    Event Number
    45947
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    JDI
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    November 15, 2007
    Posted
    February 26, 2008
    Terminated
    September 22, 2008
    Address
    325 Corporate Dr, Mahwah, NJ, 07430-2002

    Description

    Stryker Modular Replacement System Curved Cemented Stem; MRS 12mmx203 Femoral Stem. Catalog Number: 6485-3-313; Stryker Orthopaedics Mahwah, NJ 07430

    Reason

    Curvature Discrepancy -- The radius of curvature may be out of specification to varying degrees causing a discrepency in the stem curvature between trials and implants.

    Action

    On November 26, 2007, Stryker Sent Urgent Product Recall notification letters to Stryker Agencies/Branches and hospitals (OR Supervisor) by Federal Express. The notification requested that all inventory be examined and returned. Returning instructions were provided in the letter. Questions concerning this recall are being addressed by contacting the Regulatory Compliance Hotline at (201) 831-6633.

    Distribution

    Nationwide Distribution

    Quantity

    803 total, all sizes