BEUDAMED
    FDA Recall Terminated

    VariAx Compression Plating System

    Recall: Z-1507-2016 · Initiated October 10, 2013

    Recall

    Recall Number
    Z-1507-2016
    Event Number
    73505
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    HWC
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 10, 2013
    Posted
    April 18, 2016
    Terminated
    April 21, 2016
    Address
    325 Corporate Dr, Mahwah, NJ, 07430-2006

    Description

    VariAx Compression Plating System

    Reason

    Stryker received two reports indicating that during screw insertion under a high lateral angle a bone screw went through a oblong hole.

    Action

    Stryker Orthopaedics sent notification letters/product accountability forms on October 10, 2013, via email. Customers are provided the product issue, hazards and risk mitigation along with actions needed. Customers should receive the affected products and complete the BRF and return to Stryker. Questions can be directed to Stryker. For further questions, please call (201) 831-5000.

    Distribution

    Nationwide Distribution

    Quantity

    118 units