BEUDAMED
    FDA Recall 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 · Initiated February 2, 2015

    Recall

    Recall Number
    Z-1249-2015
    Event Number
    70477
    Firm
    Microport Orthopedics INC.
    FEI Number
    3010536692
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 2, 2015
    Posted
    March 6, 2015
    Terminated
    March 19, 2015
    Address
    5677 Airline Rd, Arlington, TN, 38002-9501

    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.

    Action

    MicroPort Orthopedics sent an Urgent Action Required letter dated January 29, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their stock including all consignment stock to determine if they have any affected product. If they have affected product they should return immediately to the MicroPort Orthopedics Inc. Distribution Center at 11481 Gulf Stream, Arlington, TN 38002. Mark all return shipping boxes with "RECALL" for identification and processing. Customers with questions were instructed to contact MPO's Customer Experience Department at 1-866-872-0211. For questions regarding this recall call 901-867-4324.

    Distribution

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

    Quantity

    17 units