BEUDAMED
    FDA Enforcement Class II 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 · Reported December 27, 2017

    Enforcement

    Recall Number
    Z-0266-2018
    Event ID
    78401
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medacta Usa Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 27, 2017
    Initiation Date
    October 24, 2017
    Classification Date
    December 20, 2017
    Termination Date
    June 20, 2018
    Address
    3973 Delp St, Memphis, TN, 38118-6110, United States

    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.

    Code Info

    all serial numbers

    Distribution

    nationwide

    Quantity

    12,768 units