Events

Recall of Integra

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
    60938
  • Event Risk Class
    Class 2
  • Event Number
    Z-0986-2012
  • Event Initiated Date
    2011-10-07
  • Event Date Posted
    2012-02-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-05-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106839
  • 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
    Filler, bone void, calcium compound - Product Code MQV
  • Reason
    Integra os osteoconductive putty is labeled with incorrect storage conditions.
  • Action
    Integra issued an "Urgent: Product Recall Notification" to customers and sales specialists on 10/7/2011. They were advised of the problem and provided instructions on how to handle the affected product.

Device

Integra
  • Model / Serial
    2.5 cc Part numbers - IOS10125 Lot numbers - N199416 and 215944  5 cc Part numbers - lOS10155 Lot numbers - 208500, 206504 and N216026
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution - Including the states of CA, OK, MD and VA.
  • Product Description
    Integra OS Osteoconductive Scaffold Putty (2.5 cc and 5 cc). Integra OS Putty, combined with bone marrow aspirate, is intended for use as a bone void filler to fill voids or gaps of the skeletal system. Following placement in the bony void or gap (defect), Integra OS Putty is resorbed and replaced with bone during the healing process.
  • Manufacturer
    Integra LifeSciences Corp

Manufacturer

Integra LifeSciences Corp