BEUDAMED
    FDA Enforcement Class II Terminated

    EVOLUTION MP TIBIAL BASE, REF ETPKN8SR, SIZE 8 RIGHT, TYPE PRIMARY, FIT CEMENTED, STYLE KEELED, STERILE R, Rx ONLY, MicroPort Orthopedics, Inc. Knee prosthesis component.

    Recall: Z-1249-2015 · Reported March 18, 2015

    Enforcement

    Recall Number
    Z-1249-2015
    Event ID
    70477
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Microport Orthopedics INC.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 18, 2015
    Initiation Date
    February 2, 2015
    Classification Date
    March 6, 2015
    Termination Date
    March 19, 2015
    Address
    5677 Airline Rd, N/A, Arlington, TN, 38002-9501, United States

    Description

    EVOLUTION MP TIBIAL BASE, REF ETPKN8SR, SIZE 8 RIGHT, TYPE PRIMARY, FIT CEMENTED, STYLE KEELED, STERILE R, Rx ONLY, MicroPort Orthopedics, Inc. Knee prosthesis component.

    Reason

    Some units of the EVOLUTION Tibial Base was affected by a casting tool issue which caused varying retaining wall thickness and keel offset in the finished product.

    Code Info

    Lot Numbers: 1560140, 15601401568897, 15601401570896

    Distribution

    Worldwide Distribution - USA including AL, AZ, ID, KS, KS, MO, TX, IA, WV and Internationally to Canada and The Netherlands.

    Quantity

    17 units