BEUDAMED
    FDA Enforcement Class II Terminated

    Empowr PS Knee System Box Cut Guide The EMPOWER PS Box Cut Guide is used to make the housing resection for the post of the posterior stabilized implant

    Recall: Z-0766-2017 · Reported December 21, 2016

    Enforcement

    Recall Number
    Z-0766-2017
    Event ID
    75645
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Encore Medical, Lp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 21, 2016
    Initiation Date
    September 19, 2016
    Classification Date
    December 14, 2016
    Termination Date
    October 20, 2017
    Address
    9800 Metric Blvd, Austin, TX, 78758-5445, United States

    Description

    Empowr PS Knee System Box Cut Guide The EMPOWER PS Box Cut Guide is used to make the housing resection for the post of the posterior stabilized implant

    Reason

    It has been discovered that during Empowr PS Total Knee replacement, while chiseling for bone removal in the box area, femoral chipping has occurred in surgery.

    Code Info

    202351L01, 202351L02, 202351L03, 202351L04, 202351L05, 202351L06, 202351L07, 202351L08, 202351L09, 203779L09, 202351L10, 203779L10, 203203L01

    Distribution

    Nationwide Distribution

    Quantity

    162 units