BEUDAMED
    FDA Recall 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 · Initiated April 27, 2016

    Recall

    Recall Number
    Z-1881-2016
    Event Number
    73978
    Firm
    Orthofix, Inc
    FEI Number
    2183449
    Product Code
    HXX
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 27, 2016
    Posted
    June 1, 2016
    Terminated
    November 23, 2016
    Address
    3451 Plano Pkwy, Lewisville, TX, 75056-9453

    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.

    Action

    Affected distributors will be provided a written notification of field correction via USPS Certified Mail or FedEx on 4/27/16. Distributors will be additionally instructed to provide field correction notifcations to hospitals, surgeons, or other distributors that they may have further ditributed the product to.

    Distribution

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

    Quantity

    36 units