Events

Recall of Device Recall Endura NoReact

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
    37903
  • Event Risk Class
    Class 1
  • Event Number
    Z-0832-2007
  • Event Initiated Date
    2007-05-04
  • Event Date Posted
    2007-05-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-09-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=52173
  • 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
    Dural Substitute - Product Code DTZ
  • Reason
    Integra lifesciences corporation d/b/a integra neurosciences, the distributor of endura no-react dural substitute, manufactured by shelhigh, inc., union, nj, is recalling this product based on an fda public health notification and fda requested recall letter to shelhigh citing sterility and other manufacturing concerns regarding this product manufactured by shelhigh. integra is a distributor of t.
  • Action
    On May 4, 2007, an Urgent Recall Notice and accompanying recall acknowledgement form was sent to all customers that had purchased or been supplied EnDura No-React Dural Substitute product since sale of the product was initiated in 2003. Recall Coordinators at each facility are asked to review inventory for EnDura products and to call Integra Customer Service for an authorization number for return of product.

Device

Device Recall Endura NoReact
  • Model / Serial
    Product code: ENR21212 : all lots
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution to hospitals and medical centers
  • Product Description
    EnDura No-React Dural Substitute 12 cm Diameter
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.