BEUDAMED
    FDA Recall Terminated

    VALOR(TM) TTC FUSION, INSTRUMENT KIT, REF 4150-KIT1, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002. The VALOR" Ankle Fusion Nail System is intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after tumor resection. These include Neuro-osteoarthropathy (Charcots Foot), Avascular Necrosis of the talus, failed joint replacement, failed ankle fusion, distal tibia fracture non-unions, Osteoarthritis, Rheumatoid Arthritis, and Pseudoarthrosis.

    Recall: Z-1485-2012 · Initiated April 5, 2012

    Recall

    Recall Number
    Z-1485-2012
    Event Number
    61602
    Firm
    Wright Medical Technology Inc
    FEI Number
    1043534
    Product Code
    HSB
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 5, 2012
    Posted
    May 2, 2012
    Terminated
    January 28, 2013
    Address
    5677 Airline Rd, Arlington, TN, 38002-9501

    Description

    VALOR(TM) TTC FUSION, INSTRUMENT KIT, REF 4150-KIT1, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002. The VALOR" Ankle Fusion Nail System is intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after tumor resection. These include Neuro-osteoarthropathy (Charcots Foot), Avascular Necrosis of the talus, failed joint replacement, failed ankle fusion, distal tibia fracture non-unions, Osteoarthritis, Rheumatoid Arthritis, and Pseudoarthrosis.

    Reason

    The possibility exists that the handle of the targeting guide may rotate and/or break under normal usage.

    Action

    Wright Medical Technology, Inc. sent an "URGENT PRODUCT RECALL NOTIFICATION" letter dated April 2, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to check their stock and to return the affected product to the firm. Additionally, a Product Recall Verification Form was enclosed for customers to complete and return via fax to 901-867-7401. Contact the firm at 901-867-4324 for questions regarding this notice.

    Distribution

    Worldwide Distribution-USA (nationwide) and the country of Australia.

    Quantity

    133 units