BEUDAMED
    FDA Recall Terminated

    Exactech Tibial Offset Bushing (sizes 1, 2, 3, 4, & 5) Catalog Numbers 209-04-71, 209-04-72, 209-04-73, 209-04-74, and 209-04-75.

    Recall: Z-1146-03 · Initiated July 30, 2003

    Recall

    Recall Number
    Z-1146-03
    Event Number
    26990
    Firm
    Exactech, Inc.
    FEI Number
    1038671
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 30, 2003
    Posted
    August 26, 2003
    Terminated
    May 3, 2012
    Address
    2320 N.W. 66th Court, Gainesville, FL, 32653

    Description

    Exactech Tibial Offset Bushing (sizes 1, 2, 3, 4, & 5) Catalog Numbers 209-04-71, 209-04-72, 209-04-73, 209-04-74, and 209-04-75.

    Reason

    The alpha and beta markings on the offset tibial bushings are in a location that would lead to the improper selection of an offset tibial tray.

    Action

    The firm mailed recall letters dated 7/30/2003 to direct distributor accounts requesting they cease distribution, subrecall to user accounts and return products to them at 2243 NW 66th Court, Gainesville, FL 32653. The firms were requested to respond to the recalling firm.

    Distribution

    Product was distributed directly to four distributors in OH, ME, HI and NY.

    Quantity

    137