Events

Recall of External Bone Fixation System

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
    45878
  • Event Risk Class
    Class 2
  • Event Number
    Z-0674-2008
  • Event Date Posted
    2008-02-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-03-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66393
  • 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
    bone distractor - Product Code LXT
  • Reason
    Markings reversed: graduated markings on telescoping bone distractors were reversed, causing the distractors to compress rather than distract the treatment site when adjusted.
  • Action
    Orthofix notified sales agents by phone starting on 09/28/07. Sales agents were to return product for replacements.

Device

External Bone Fixation System
  • Model / Serial
    Lot numbers:  For Catalog #50-1101 (75mm): 075; For Catalog #50-1014 (100mm): 7241, 076 and 50826; For Catalog #50-1015 (150mm): 2664-01, 7343 and 080; For Catalog #50-1016 (200mm): 145, 7342 and 068.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution - USA states: CA, FL, GA, IL, PA, MI, NY and WI.
  • Product Description
    Orthofix TrueLok External Ring Fixation System, Telescopic Linear Distractor, Threaded in the following sizes: 75mm (Catalog Number: 50-1101), 100mm (Catalog Number: 50-1014), 150mm (Catalog Number: 50-1015) and 200mm (Catalog Number: 50-1016), distributed by Orthofix, Inc., McKinney, TX 75069.
  • Manufacturer
    Orthofix, Inc

Manufacturer

Orthofix, Inc
  • Manufacturer Address
    Orthofix, Inc, 1720 Bray Central Dr, Mckinney TX 75069-8207
  • Manufacturer Parent Company (2017)
    Orthofix International Nv
  • Source
    USFDA