BEUDAMED
    FDA Recall Terminated

    3DKnee e+ Tibial Insert. The insert is used along with the other components that comprise the 3DKnee System.

    Recall: Z-1213-2013 · Initiated April 1, 2013

    Recall

    Recall Number
    Z-1213-2013
    Event Number
    64859
    FEI Number
    1000116912
    Product Code
    OIY
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    April 1, 2013
    Posted
    May 2, 2013
    Terminated
    July 1, 2013
    Address
    9800 Metric Blvd, Encore Medical, Lp, Austin, TX, 78758

    Description

    3DKnee e+ Tibial Insert. The insert is used along with the other components that comprise the 3DKnee System.

    Reason

    U.S. Agent contacted Director Commercial Logistics, notifying him of incorrect color coded labels on two packages of e+tibial inserts. There were 8 e+ tibial inserts of the same lot number in Finished Goods as the two from the agency. These devices were inspected and all were incorrectly labeled.

    Action

    The firm sent their US customer a "Urgent Field Safety Notice" letter on April 1, 2013. The letter explained the product problem and provided recommended actions as well as customer contact numbers.

    Distribution

    US Distribution to the state of California and International Distribution to the country of Venezuela.

    Quantity

    5