BEUDAMED
    FDA Recall Terminated

    Vilex, Inc., FUZE 10.0 mm x 150 mm, Product # FZ100-150T-25. Ankle arthrodesis, tibio-talo-calcaneal arthrodesis.

    Recall: Z-1721-2015 · Initiated April 22, 2015

    Recall

    Recall Number
    Z-1721-2015
    Event Number
    71344
    Firm
    Vilex In Tennessee Inc
    FEI Number
    1051526
    Product Code
    HSB
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 22, 2015
    Posted
    June 8, 2015
    Terminated
    October 30, 2016
    Address
    111 Moffitt Street, Mcminnville, TN, 37110-2235

    Description

    Vilex, Inc., FUZE 10.0 mm x 150 mm, Product # FZ100-150T-25. Ankle arthrodesis, tibio-talo-calcaneal arthrodesis.

    Reason

    Incidence of breakage is higher than expected.

    Action

    The initial telephone call (4/9/2015) informed the distributor that the product was on hold (not to be used or transferred). The second telephone call (4/29/2015) and letter informed the customer that the product was being removed from market and that the customer was to return the product to the corporate office. The letter was disseminated on 05/05/2015 to distributors via certified mail. The letter contains the instructions for them to follow, which as summarized are: inventory all products on hand, sign off on inventory sheet, send products back to the corporate office with the identified return number on the shipping container, inform the corporate office that the process has been completed and provide the corporate office with the list of the products returned. A second letter was disseminated to sales representatives (distributors), surgeons, and hospitals on 05/28/2015.

    Distribution

    Distributed in the states of MS, MD, PA, and TX.

    Quantity

    13 units