BEUDAMED
    FDA Recall 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 · Initiated September 19, 2016

    Recall

    Recall Number
    Z-0766-2017
    Event Number
    75645
    FEI Number
    1000116912
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 19, 2016
    Terminated
    October 20, 2017
    Address
    9800 Metric Blvd, Encore Medical, Lp, Austin, TX, 78758-5445

    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.

    Action

    DJO Global sent an Urgent Field Safety Notice dated September 19, 2016, to all affected customers. The field safety notice provided a newly revised Surgical Technique to educate users on proper use of the device. Customers were instructed to become familiar with the new surgical techniques and notify all of their applicable users of the revised methods. Customers were also instructed to sign the Acknowledgement and Receipt Form. Customers with questions were advised to call 760-734-3551. For questions regarding this recall call 512-832-6302.

    Distribution

    Nationwide Distribution

    Quantity

    162 units