BEUDAMED
    FDA Enforcement Class II Terminated

    Vilex, Inc., FUZE 10.0 mm x 250 mm, Product # FZ100-250T-25. Ankle arthrodesis, tibio-talo-calcaneal arthrodesis.

    Recall: Z-1723-2015 · Reported June 17, 2015

    Enforcement

    Recall Number
    Z-1723-2015
    Event ID
    71344
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Vilex In Tennessee Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    June 17, 2015
    Initiation Date
    April 22, 2015
    Classification Date
    June 8, 2015
    Termination Date
    October 30, 2016
    Address
    111 Moffitt Street, N/A, Mcminnville, TN, 37110-2235, United States

    Description

    Vilex, Inc., FUZE 10.0 mm x 250 mm, Product # FZ100-250T-25. Ankle arthrodesis, tibio-talo-calcaneal arthrodesis.

    Reason

    Incidence of breakage is higher than expected.

    Code Info

    all codes

    Distribution

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

    Quantity

    4 units