Events

Recall of Device Recall Rod Connector Assembly

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
    64265
  • Event Risk Class
    Class 2
  • Event Number
    Z-0896-2013
  • Event Initiated Date
    2013-02-01
  • Event Date Posted
    2013-02-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-07-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115728
  • 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
    There is a possibility that the set screw (p/n 90-2923) sub-component of the parallel rod connector assembly (p/n 52-6800) & axial rod connector (p/n 52-6700) may crack during final tightening. orthofix inc received six (6) customer complaints related to set screw cracking between november 15, 2010 and december 2012.
  • Action
    Orthofix sent an Urgent Medical Device Recall Notification dated February 1, 2013 to all affected customers. The letter identifed the affected product, problem and actions to be taken. Customers were instructed to identify and remove the affected products from inventory immediately and follow the actions listed in the enclosed Product Return Instructions. For questions or concerns contact Regulatory Affairs at 214-937-2100.

Device

Device Recall Rod Connector Assembly
  • Model / Serial
    Catalog Numbers: 52-6800 & 52-6700; All Lot Numbers
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwidewide Distribution - USA Nationwide including Puerto Rico and the countries of: Australia, Lebanon, Germany, Spain, Sweden and Israel.
  • Product Description
    Firebird Spinal Fixation System, Parallel Rod Connector (52-6800) and Axial Rod Connector (52-6700). || Product Usage: || The connector assemblies allow for rod components to be connected side-to-side, or end-to-end and eliminate the need of rebuilding the entire system with a longer rod in order to include the new vertebral levels.
  • 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