BEUDAMED
    FDA Enforcement Class II Terminated

    GMK Hinge knee prosthesis; Model Number: 02.09.TA410; Orthopedics and Orthopedic Surgery

    Recall: Z-0275-2016 · Reported November 25, 2015

    Enforcement

    Recall Number
    Z-0275-2016
    Event ID
    71121
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medacta Usa
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 25, 2015
    Initiation Date
    April 17, 2015
    Classification Date
    November 13, 2015
    Termination Date
    January 5, 2017
    Address
    1556 W Carroll Ave, N/A, Chicago, IL, 60607-1012, United States

    Description

    GMK Hinge knee prosthesis; Model Number: 02.09.TA410; Orthopedics and Orthopedic Surgery

    Reason

    Incorrect parts: Packages of the GMK Hinge Tibial Augmentation size 4-10 mm have 5 mm screws instead of 10 mm screws.

    Code Info

    Lot: 145129

    Distribution

    Distributed in the states of IL, OH and UT, and the countries of in Austria, Spain, Australia, France and Switzerland.

    Quantity

    4 units (US)