BEUDAMED
    FDA Enforcement Class II Terminated

    Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H, STERILE EO

    Recall: Z-2661-2017 · Reported July 12, 2017

    Enforcement

    Recall Number
    Z-2661-2017
    Event ID
    77467
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medacta Usa Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    July 12, 2017
    Initiation Date
    May 19, 2017
    Classification Date
    July 3, 2017
    Termination Date
    May 29, 2018
    Address
    3973 Delp St, N/A, Memphis, TN, 38118-6110, United States

    Description

    Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H, STERILE EO

    Reason

    One lot of product does not include a screw for attachment to the tibial base plate.

    Code Info

    Lot # 163646

    Distribution

    CA, AZ, NC, Israel, France

    Quantity

    4 units