BEUDAMED
    FDA Recall Terminated

    The GMK knee system: designed for cemented use in total knee arthroplasty. Sphere and Primary Inserts with part number ranges: 02.12.0110FL - 02.12.0620FL; 02.12.0110FR - 02.12.0620FR; 02.07.0110PSF - 02.07.0620PSF

    Recall: Z-0266-2018 · Initiated October 24, 2017

    Recall

    Recall Number
    Z-0266-2018
    Event Number
    78401
    Firm
    Medacta Usa Inc
    FEI Number
    3006639916
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 24, 2017
    Posted
    December 20, 2017
    Terminated
    June 20, 2018
    Address
    3973 Delp St, Memphis, TN, 38118-6110

    Description

    The GMK knee system: designed for cemented use in total knee arthroplasty. Sphere and Primary Inserts with part number ranges: 02.12.0110FL - 02.12.0620FL; 02.12.0110FR - 02.12.0620FR; 02.07.0110PSF - 02.07.0620PSF

    Reason

    Medacta has observed a worldwide occurrence rate of post-operative insert screw back-out of approximately 0.1%. For this reason, we stress the importance of using the 3.5 Nm torque limiting driver if the screw is used, as directed in our surgical techniques.

    Action

    All surgeon customers shall be notified via email by October 24, 2017 of the reminder to follow the surgical technique. To ensure that surgeons receive the notification, we will send the letter via email so that we can track and ensure the message was received. If the email is returned, we would then send a personalized letter directly to the surgeon. A copy of this notification is included with the submission of this report.

    Distribution

    nationwide

    Quantity

    12,768 units