BEUDAMED
    FDA Enforcement Class II Terminated

    Orthofix Firebird Spinal Fixation System Instrumentation Modular Screw Driver, Product Usage: The Modular Screw Driver is used for inserting a modular bone screw into the pedicle during a spinal fixation procedure. It is a reusable instrument.

    Recall: Z-0855-2014 · Reported February 5, 2014

    Enforcement

    Recall Number
    Z-0855-2014
    Event ID
    66969
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Orthofix, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 5, 2014
    Initiation Date
    November 26, 2013
    Classification Date
    January 28, 2014
    Termination Date
    December 9, 2014
    Address
    3451 Plano Pkwy, Lewisville, TX, 75056-9453, United States

    Description

    Orthofix Firebird Spinal Fixation System Instrumentation Modular Screw Driver, Product Usage: The Modular Screw Driver is used for inserting a modular bone screw into the pedicle during a spinal fixation procedure. It is a reusable instrument.

    Reason

    Orthofix received 6 complaints which resulted in a reportable events due to extended surgical times greater than 30 minutes for the Modular Screw Driver (PN 52-1332). The complaints alleged that the screw driver's collet would malfunction resulting in the surgeon being unable to use the Modular Screw Driver to effectively place Modular Screws, which may result in a delay of surgery.

    Code Info

    Production Identification Numbers: Part Number 52-1332, All Lot Numbers.

    Distribution

    Worldwide Distribution - US Nationwide including (Puerto Rico) and the countries of: Spain, Germany, Australia, Peru, Mexico, Colombia, South Africa, and Israel.

    Quantity

    443