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U.S. Department of Health and Human Services

Medical Devices

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Integra LifeSciences Corporation (also known as Integra NeuroSciences) EnDura™ No-React® Dural Substitute

Class 1 Recall
Date Recall
Initiated:
May 4, 2007
Product:

EnDura™ No-React® Dural Substitute distributed by Integra LifeSciences Corporation and manufactured by Shelhigh, Inc.

Products Include:

ENR20210 EnDura™ No-React® Dural Substitute 2cm x 10 cm
ENR20404 EnDura™ No-React® Dural Substitute 4cm x 4 cm
ENR20506 EnDura™ No-React® Dural Substitute 5cm x 6cm
ENR20610 EnDura™ No-React® Dural Substitute 6cm x 10cm
ENR21012 EnDura™ No-React® Dural Substitute 10cm x 12cm
ENR21212 EnDura™ No-React® Dural Substitute 12cm Diameter

The EnDura™ products are the only products manufactured by Shelhigh Inc. that are distributed by Integra.

Use:
EnDura™ No-React® Dural Substitute is used to repair the dura mater during neurosurgery (brain surgery). The dura mater is the tough fibrous membrane covering the brain and the spinal cord and lining the inner surface of the skull.
Recalling Firm:

Integra Life Sciences Corp.
311 Enterprise Drive
Plainsboro, NJ 08536-3344

Reason for Recall:
The environmental controls and processes used to manufacture these devices within the Shelhigh, Inc. facility in Union, New Jersey can compromise the sterility of these products. The use of non-sterile products in patients can lead to life-threatening infections.
Public Contact:

Integra LifeSciences Corp. Service Department
1-800-456-8482

FDA District:
New Jersey
FDA Comment:
  • Integra stopped shipping and quarantined all EnDura™ products on April 18, 2007, the day FDA issued its Preliminary Public Health Notification regarding devices manufactured by Shelhigh, Inc.
  • On April 20, 2007, Integra notified hospitals by letter of Integra’s stop shipment of EnDura™ Products.
  • On May 4, 2007, Integra sent an Urgent Recall Notice and accompanying recall acknowledgement form to all customers that had purchased or been supplied
    EnDura™ products since the devices were first sold in 2003.
  • Integra asked recall coordinators at each facility to review their inventory for the EnDura™ products and to call Integra Customer Service for an authorization number for return of the products. A second notification letter was sent to all non-responders. All returned products will be placed in quarantine.
  • Integra will account for all recall acknowledgement form responses and product returns.
  • Integra will arrange to dispose of the recalled products when the company receives all the products that were sold.

Patients who have had brain surgery since October 2003 and have concerns or questions should contact their doctor.

For more information see nearby links.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program.  See the nearby link to MedWatch.