BEUDAMED
    FDA Enforcement Class II Terminated

    Empowr Knee System Product Usage: Non-porous proximal tibial baseplate implants, utilized in either posterior cruciate ligament (PCL) retaining or PCL substituting total knee arthroplasty procedure.

    Recall: Z-0711-2017 · Reported December 14, 2016

    Enforcement

    Recall Number
    Z-0711-2017
    Event ID
    75715
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Encore Medical, Lp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 14, 2016
    Initiation Date
    November 15, 2016
    Classification Date
    December 6, 2016
    Termination Date
    January 20, 2017
    Address
    9800 Metric Blvd, N/A, Austin, TX, 78758-5445, United States

    Description

    Empowr Knee System Product Usage: Non-porous proximal tibial baseplate implants, utilized in either posterior cruciate ligament (PCL) retaining or PCL substituting total knee arthroplasty procedure.

    Reason

    A size 4 Empowr baseplate was mislabeled as a size 6. The affected lot was laser marked as M6, marked with the lot number for the size 6 minus lot, and distributed as size 6 minus.

    Code Info

    033T1022

    Distribution

    US Nationwide Distribution in the states of CO, IL, IN, FL, CA, AZ

    Quantity

    7 units