BEUDAMED
    FDA Recall Terminated

    Optetrak, B-series cemented finned tibial tray size 2f/2t. Catalog # 220-04-02

    Recall: Z-0196-2007 · Initiated August 31, 2006

    Recall

    Recall Number
    Z-0196-2007
    Event Number
    36311
    Firm
    Exactech, Inc.
    FEI Number
    1038671
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 31, 2006
    Posted
    November 21, 2006
    Terminated
    May 3, 2012
    Address
    2320 NW 66th Ct, Gainesville, FL, 32653-1630

    Description

    Optetrak, B-series cemented finned tibial tray size 2f/2t. Catalog # 220-04-02

    Reason

    Improperly machined parts: The Cemented Finned Tibial Trays could not seat the size 2 mating trial or polyethylene insert.

    Action

    The recall was initiated on August 31, 2006. The distributors were notified by FAX, email and telephone. The returned devices will be stored quarantine.

    Distribution

    International distribution only---- including countries of South America, Africa and Europe

    Quantity

    30