BEUDAMED
    FDA Recall Terminated

    Zimmer brand Coonrad/Morrey total elbow interchangeable ulnar assembly, small, left, 3 in. length. tivanium TI-6AL-4V alloy/UHMWPE, sterile, for use with bone cement. Cat. no. 32-8105-53-01.

    Recall: Z-0767-04 · Initiated March 16, 2004

    Recall

    Recall Number
    Z-0767-04
    Event Number
    28576
    Firm
    Zimmer Inc.
    FEI Number
    1000220733
    Product Code
    JDC
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 16, 2004
    Posted
    July 20, 2004
    Terminated
    June 26, 2004
    Address
    345 E Main St, Warsaw, IN, 46580-2746

    Description

    Zimmer brand Coonrad/Morrey total elbow interchangeable ulnar assembly, small, left, 3 in. length. tivanium TI-6AL-4V alloy/UHMWPE, sterile, for use with bone cement. Cat. no. 32-8105-53-01.

    Reason

    Right ulna implants were etched and labeled as left ulna implants. Left ulna implants may have been etched and labeled as right ulna implants.

    Action

    Consignees were notified via e-mail on 3/16/04. Consignees were asked to secure their inventory from use and to notify all customers if they had further distributed the product. Product shipped to Japan and Singapore was contained prior to shipment to hospitals.

    Distribution

    United States, Australia, Canada, Finland, France, Germany, Israel, Italy, Japan, Korea, Singapore, Spain, and the United Kingdom.