Events

Recall of Device Recall Orthofix

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
    66969
  • Event Risk Class
    Class 2
  • Event Number
    Z-0855-2014
  • Event Initiated Date
    2013-11-26
  • Event Date Posted
    2014-01-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-12-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124351
  • 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
    Appliance, fixation, spinal interlaminal - Product Code KWP
  • 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.
  • Action
    Orthofix sent an Urgent Medical Device Recall Notification letter dated November 26, 2013 by certified mail to distributors. The letter identified the affected product, problem and actions to be taken. The letter instructed distributors to immediately cease any further distribution, return affected products to Orthofix at no cost and complete the attached reply form. For questions contact your local Orthofix representative.

Device

Device Recall Orthofix
  • Model / Serial
    Production Identification Numbers: Part Number 52-1332, All Lot Numbers.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - US Nationwide including (Puerto Rico) and the countries of: Spain, Germany, Australia, Peru, Mexico, Colombia, South Africa, and Israel.
  • Product 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.
  • 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