BEUDAMED
    FDA Recall Terminated

    Empowr PS Knee Tibial Insert; Model 343-14-709 The EMPOWR PS tibial insert are made from Highly Cross-Linked Vitamin E (HXL VE) UHMWPE. The tibial insert implants are intended to mate with tibial base implants.

    Recall: Z-1139-2017 · Initiated January 10, 2017

    Recall

    Recall Number
    Z-1139-2017
    Event Number
    76206
    FEI Number
    1000116912
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    January 10, 2017
    Posted
    February 3, 2017
    Terminated
    May 11, 2017
    Address
    9800 Metric Blvd, Encore Medical, Lp, Austin, TX, 78758-5445

    Description

    Empowr PS Knee Tibial Insert; Model 343-14-709 The EMPOWR PS tibial insert are made from Highly Cross-Linked Vitamin E (HXL VE) UHMWPE. The tibial insert implants are intended to mate with tibial base implants.

    Reason

    The Empowr PS Insert was reported as missing the impaction slot feature.

    Action

    DJO Global sent an Urgent Field Safety Notice dated January 10, 2017, to all affected customers. The Field Safety Notice instructs the agents to notify all individuals within their organization or to any organization where the potentially affected product has been transferred. Customers with questions should contact customer service at 1-800-456-8696. For questions regarding this recall call 512-832-9500.

    Distribution

    Nationwide Distribution to CO, NY, and FL

    Quantity

    24 units