Events

Recall of Firebird NXG Spinal Fixation System Decorticating Planer

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Orthofix, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    77882
  • Event Risk Class
    Class 2
  • Event Number
    Z-3127-2017
  • Event Initiated Date
    2017-08-02
  • Event Date Posted
    2017-08-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-05-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158127
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Thoracolumbosacral pedicle screw system - Product Code NKB
  • 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.
  • Action
    Orthofix sent an Urgent Medical Device Product Recall letter dated August 2, 2017, to all affected customers. The letter explained the issue and requested return of product in their possession. Customers with questions were instructed to contact their local Orthofix representative. For questions regarding this recall call 214-937-2100.

Device

Firebird NXG Spinal Fixation System Decorticating Planer
  • Model / Serial
    Lot #203013-TD26
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distribution was made to distributors located in CA, FL, and RI. There was no foreign/military/government distribution.
  • Product 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
  • Manufacturer
    Orthofix, Inc

Manufacturer

Orthofix, Inc
  • Manufacturer Address
    Orthofix, Inc, 3451 Plano Pkwy, Lewisville TX 75056-9453
  • Manufacturer Parent Company (2017)
    Orthofix International Nv
  • Source
    USFDA