BEUDAMED
    FDA Enforcement Class II 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 · Reported February 15, 2017

    Enforcement

    Recall Number
    Z-1139-2017
    Event ID
    76206
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Encore Medical, Lp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 15, 2017
    Initiation Date
    January 10, 2017
    Classification Date
    February 3, 2017
    Termination Date
    May 11, 2017
    Address
    9800 Metric Blvd, N/A, Austin, TX, 78758-5445, United States

    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.

    Code Info

    035U1000

    Distribution

    Nationwide Distribution to CO, NY, and FL

    Quantity

    24 units