BEUDAMED
    FDA Recall Terminated

    Biomet CC Cruciate Tibial Tray, 67 mm.; Product No. 141232, Biomet, Inc., Warsaw, IN 46581

    Recall: Z-0706-2008 · Initiated December 12, 2007

    Recall

    Recall Number
    Z-0706-2008
    Event Number
    46141
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    December 12, 2007
    Posted
    January 31, 2008
    Terminated
    June 11, 2008
    Address
    56 E Bell Dr, Warsaw, IN, 46581-0587

    Description

    Biomet CC Cruciate Tibial Tray, 67 mm.; Product No. 141232, Biomet, Inc., Warsaw, IN 46581

    Reason

    Mislabeled as to size: Package labeled as containing a 67 mm tray actually contains a 75 mm tray and vice versa.

    Action

    Consignees were notified via an Urgent Medical Device Recall Notice dated 12/12/07 to cease use of the product and to return it.

    Distribution

    Worldwide: USA including states of Georgia, Idaho, Indiana, Missouri, Ohio, and Virginia and country of Turkey.

    Quantity

    8