Events

Recall of Integra Surgical

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
    60214
  • Event Risk Class
    Class 2
  • Event Number
    Z-0378-2012
  • Event Initiated Date
    2011-10-10
  • Event Date Posted
    2012-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-10-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104789
  • 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
    Light, surgical, fiberoptic - Product Code FST
  • Reason
    Headlight assembly (module) may become loose and separate from the headband assembly.
  • Action
    Integra Life Sciences notified consignees by URGENT DEVICE RECALL letter dated October 10, 2011, via FedEx, email or telephone conference calls. The letter identified the affected product, the problem, and the actions to be taken. Customers were instructed to identify and return any affected product. Customers were requested to complete and return the attached Field Corrective Action Acknowledgement Form to Integra Surgical indicating receipt and review of this notification. For assistance and additional information contact your local and Integra Sales Representative or call Integra Surgical Customer Service at 1-800-431-1123.

Device

Integra Surgical
  • Model / Serial
    All serial numbers
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) including Puerto Rico, and the countries of: Africa, Algeria, Australia, Austria, Brazil, Canada, Check Republic, China, Chile, Costa Rica, Denmark, Dominican Republic, Ecuador, Ethiopia, Finland, France, Georgia, Germany, Greece Hungary, Guatemala, India, Ireland, Israel, Italy, Iraq, Japan, Jordan, Kenya, Kuwait, Lebanon, Lithuania, Macedonia, Mexico, Netherlands, New Zealand! Norway, Oman, Pakistan, Peru Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad, Turkey, Qatar, United Kingdom, Yemeni United Arab Emirates, Uruguay, and Venezuela.
  • Product Description
    UltraLite Headlight module-grey || Model: 001328 || Product Usage: The fiber optic headlight system Is designed to deliver illumination from a high intensity light source for surgical site illumination.
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.