FYI on EnDura Patches prior to May '07

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

For more info :
http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm062486.htm