BEUDAMED
    FDA Recall Terminated

    Triathlon MIS Modular Capture;Catalog Number: 6541-5-723; Stryker Orthopaedics, Mahwah, New Jersey

    Recall: Z-0450-2008 · Initiated September 19, 2006

    Recall

    Recall Number
    Z-0450-2008
    Event Number
    45540
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 19, 2006
    Posted
    December 11, 2007
    Terminated
    January 18, 2008
    Address
    325 Corporate Dr, Mahwah, NJ, 07430-2002

    Description

    Triathlon MIS Modular Capture;Catalog Number: 6541-5-723; Stryker Orthopaedics, Mahwah, New Jersey

    Reason

    Assembly problems: MIS instruments (Triathlon MIS AP Sizer Body - Left; Triathlon MIS Sizer Body - Right; Triathlon MIS Femoral Adjustment Block and Triathlon MIS Modular Capture) may not assemble properly.

    Action

    Important Product Correction letters and Product Accountability Forms were sent via Federal Express on 9/19/06 with return receipt. Foreign locations were notified by a Advisory Notice. Notification letters requested that all inventory of the affected items be examined to verify that it assemble correctly. Any product that does not assemble correctly was to be returned to Stryker, Mahwah, NJ. The Product Accountability form was to be completed by each location to notify Stryker that the letter ahd been received and inventory examined. Stryker representatives were to be contacted for product replacement.

    Distribution

    Worldwide: USA including states of MI and IL. and countries of Australia, China, New Zealand, Singapore, France, Germany, Italy, Portugal, Spain, Sweden and UK.

    Quantity

    2,868 units total for Recalls Z-0448-0450-2008