BEUDAMED
    FDA Recall Terminated

    Zimmer Coonrad/Morrey Total Elbow, Interchangeable Humeral Assembly, extra small, 4 inch length, sterile, Zimmer Inc., Warsaw, IN; REF 32-8105-027-04. The device is utilized for a total elbow arthroplasty surgical procedure.

    Recall: Z-1053-2009 · Initiated January 30, 2009

    Recall

    Recall Number
    Z-1053-2009
    Event Number
    50914
    Firm
    Zimmer Inc.
    FEI Number
    1000220733
    Product Code
    JDC
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    January 30, 2009
    Posted
    April 2, 2009
    Terminated
    December 22, 2009
    Address
    345 E Main St, Warsaw, IN, 46580-2746

    Description

    Zimmer Coonrad/Morrey Total Elbow, Interchangeable Humeral Assembly, extra small, 4 inch length, sterile, Zimmer Inc., Warsaw, IN; REF 32-8105-027-04. The device is utilized for a total elbow arthroplasty surgical procedure.

    Reason

    The surgical technique is inadequate for extra-small sized implants, resulting in the possibility of the provisional becoming stuck in the bone.

    Action

    Consignees were notified by "Urgent Device Correction" letter dated January 30, 2009 and provided revised surgical techniques for these extra-small implants. Direct questions about this recall to Zimmer, Inc. at 574-267-6131.

    Distribution

    Worldwide Distribution, including USA, Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Czech Republic, Denmark, England, Finland, France, Germany, Hong Kong, Hungary, India, Italy, Japan, Jordan, Latin America, Netherlands, Russia, Singapore, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey and Venezuela.

    Quantity

    14,613 of all products