BEUDAMED
    FDA Enforcement Class II Terminated

    Firebird NXG Spinal Fixation System Decorticating Planer, Catalog #36-1334, non-sterile, Rx. .A Decorticating Planer is used to decorticate bone surrounding the spherical head of an implanted bone screw in order to provide clearance to allow for proper seating of the modular body, as well as to provide full range of modular body angulation. It is placed axially over the spherical head of the bone screw and rotated clockwise and counterclockwise to achieve the needed decortication

    Recall: Z-3127-2017 · Reported September 20, 2017

    Enforcement

    Recall Number
    Z-3127-2017
    Event ID
    77882
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Orthofix, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 20, 2017
    Initiation Date
    August 2, 2017
    Classification Date
    September 12, 2017
    Termination Date
    May 4, 2018
    Address
    3451 Plano Pkwy, N/A, Lewisville, TX, 75056-9453, United States

    Description

    Firebird NXG Spinal Fixation System Decorticating Planer, Catalog #36-1334, non-sterile, Rx. .A Decorticating Planer is used to decorticate bone surrounding the spherical head of an implanted bone screw in order to provide clearance to allow for proper seating of the modular body, as well as to provide full range of modular body angulation. It is placed axially over the spherical head of the bone screw and rotated clockwise and counterclockwise to achieve the needed decortication

    Reason

    The plastic core of the Decorticating Planer was found to be missing, which could result in scoring of the bone screw neck if used at or beyond a 23 degree angle.

    Code Info

    Lot #203013-TD26

    Distribution

    Distribution was made to distributors located in CA, FL, and RI. There was no foreign/military/government distribution.

    Quantity

    6 planers