Events

Recall of Device Recall Integra External Fixation System Rocker Bottom Model 12225400

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

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
    74583
  • Event Risk Class
    Class 2
  • Event Number
    Z-2296-2016
  • Event Initiated Date
    2016-07-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-12-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147962
  • 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, nail/blade/plate combination, multiple component - Product Code KTT
  • Reason
    The silicone insert embedded in the rocker bottom has the potential to become dislodged or loose from the rocker bottom mold.
  • Action
    All affected consignees were notified via an "Urgent: Voluntary Medical Device Recall" letter sent on 7/1/16. The letter identified the affected product as well as the reason for the recall. Customers were asked to check their traceability records for shipments of the affected product. If the affected parts are found, customers are to stop use and distribution. A copy of the letter should be provided to any customers that the product may have been distributed to. The attached "Acknowledgement and Return Form" should be completed and returned regardless if customers have affected product or not. Questions regarding the instructions should be directed to Customer Service at 1-800-654-2873.

Device

Device Recall Integra External Fixation System Rocker Bottom Model 12225400
  • Model / Serial
    Lot # PN625.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed in the US to the states of FL, VA, OK, CO, DC, and IN.
  • Product Description
    Integra External Fixation System Rocker Bottom Model # 12225400. || For use in the treatment of bone conditions amenable to treatment by the use of external fixation.
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.