BEUDAMED
    FDA Enforcement Class II Terminated

    3DKnee e+ Tibial Insert - HXLPE-VE, Sterile, Material: Highly cross linked vitamin E PE, Sz 2/9mm. The insert is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along lateral condyle. This insert is to be used along with the other components that comprise the 3DKnee System.

    Recall: Z-2302-2012 · Reported September 5, 2012

    Enforcement

    Recall Number
    Z-2302-2012
    Event ID
    62801
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Encore Medical, Lp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 5, 2012
    Initiation Date
    August 9, 2012
    Classification Date
    August 30, 2012
    Termination Date
    January 25, 2013
    Address
    9800 Metric Blvd, N/A, Austin, TX, 78758, United States

    Description

    3DKnee e+ Tibial Insert - HXLPE-VE, Sterile, Material: Highly cross linked vitamin E PE, Sz 2/9mm. The insert is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along lateral condyle. This insert is to be used along with the other components that comprise the 3DKnee System.

    Reason

    The firm is recalling one lot of 392-09-706, 3DKnee e+ Tibial insert, 9 mm, Size 6, Right. The shelf life labeling of specific lots for a component were found to be incorrect and were found to be expired.

    Code Info

    Model Number 392-09-706, Lot Number 59602519

    Distribution

    Worldwide Distribution including Venezuela.

    Quantity

    7 units