BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-1213-2013 · Reported May 8, 2013

    Enforcement

    Recall Number
    Z-1213-2013
    Event ID
    64859
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Encore Medical, Lp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 8, 2013
    Initiation Date
    April 1, 2013
    Classification Date
    May 2, 2013
    Termination Date
    July 1, 2013
    Address
    9800 Metric Blvd, Austin, TX, 78758, United States

    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.

    Code Info

    Model/Catalog Number 391-15-708. Lot/Serial Number 59602230.

    Distribution

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

    Quantity

    5