BEUDAMED
    FDA Recall Terminated

    3DKNEE SYSTEM, 3D Knee Tibial Insert-DCM, Sterile, Right, size 4 x 11mm. Encore Medical, LP. Austin, TX 78758-5445. Intended to aid the surgion in relieving the patient of knee pain and restoring knee joint function.

    Recall: Z-1433-2010 · Initiated March 19, 2010

    Recall

    Recall Number
    Z-1433-2010
    Event Number
    55171
    FEI Number
    1000116912
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    March 19, 2010
    Posted
    April 26, 2010
    Terminated
    July 22, 2010
    Address
    9800 Metric Blvd, Encore Medical, Lp, Austin, TX, 78758

    Description

    3DKNEE SYSTEM, 3D Knee Tibial Insert-DCM, Sterile, Right, size 4 x 11mm. Encore Medical, LP. Austin, TX 78758-5445. Intended to aid the surgion in relieving the patient of knee pain and restoring knee joint function.

    Reason

    Affected product had incorrect color label which is a secondary visual indicator for sizing.

    Action

    Encore Medical, LP notified consignees by e-mail dated March 19, 2010. Consignees were requested to return the affected product to the firm. For further information, contact Encore Medical, LP at 1-888-838-3668.

    Distribution

    Worldwide Distribution -- United States (UT, IA) and Germany.

    Quantity

    7 units