BEUDAMED
    FDA Enforcement Class II Terminated

    Firebird NXG Spinal Fixation System Set Screw Driver used to insert a set screw into a spinal fixation construct. Rx Only Provided non Sterile.

    Recall: Z-1881-2016 · Reported June 8, 2016

    Enforcement

    Recall Number
    Z-1881-2016
    Event ID
    73978
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Orthofix, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 8, 2016
    Initiation Date
    April 27, 2016
    Classification Date
    June 1, 2016
    Termination Date
    November 23, 2016
    Address
    3451 Plano Pkwy, N/A, Lewisville, TX, 75056-9453, United States

    Description

    Firebird NXG Spinal Fixation System Set Screw Driver used to insert a set screw into a spinal fixation construct. Rx Only Provided non Sterile.

    Reason

    There is a possibility that the subject set screw driver could disengage from the torque limiting handle when the counter torque wrench is allowed to contact the counter torque handle.

    Code Info

    All lots

    Distribution

    KS, NV, TX, CA, ID, FL, MA, MI, NJ, AZ, NH, SC, UT, WA

    Quantity

    36 units