Events

Recall of Device Recall Integra External Fixation System

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
    74757
  • Event Risk Class
    Class 2
  • Event Number
    Z-2386-2016
  • Event Initiated Date
    2016-07-20
  • 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=148394
  • 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
    Through the investigation of reported complaints integra verified that there have been instances where the universal wire fixation bolts the slotted post broke during use at the surgical site.
  • Action
    Integra sent an Urgent - Voluntary Medical Device Recall letter dated July 20, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Integra is asking you to take the following actions: 1. Please check your Integra¿ External Fixation System inventory to determine if you have the 17.5mm or 23mm Universal Wire Fixation Bolts and/or the large or small Slotted Posts. 2. If you do have 17.5mm or 23mm Universal Wire Fixation Bolts and/or large or small Slotted Posts, stop using them immediately. 3. Complete the attached "Acknowledgement and Return Form" and check the box: I do have affected products on the list and record the lot number. 4. Or, complete the attached "Acknowledgement and Return Form" and check the box: I do not have affected products. 5. Complete the other information as indicated on this form. Keep a copy of the form for your records. Return the completed "Acknowledgement and Return Form" by email or fax indicating your receipt and review of this notification. When your form is received, if you have noted you have affected products, an Integra Representative will contact you and provide you with directions to return the product, as well as input an order to replace the quantity you indicated on the form. Receipt of this form ensures that Integra has achieved a level of effectiveness in communicating this information. We recommend you also maintain a copy of this notification and signed copy of the acknowledgement form for your records. Regulatory agencies such as the FDA perform audits of field actions of this nature to verify that our customers have been notified and understand the nature of the field action. Should you have any questions regarding these instructions, please contact Sales Operations at 888-601-0203, option 2. We apologize for any inconvenience this may cause and thank you for your cooperation in this effort. Fo

Device

Device Recall Integra External Fixation System
  • Model / Serial
    Lot # GT0420 and GT0419
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Distribution to the states of : FL, VA, OK, CO, DC and IN.
  • Product Description
    Integra External Fixation System Universal Wire Fixation Bolt - 17.5 mm Catalogue #12224218 ; Integra External Fixation System Universal Wire Fixation Bolt - 23 mm Catalogue #12224219
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.