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 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: |
Patients who have had brain surgery since October 2003 and have concerns or questions should contact their doctor.
*FDA/CDRH Preliminary Advice for Patients is intended to quickly share device-related safety information with the public when the available information and FDA’s Patients can read Integra LifeSciences Corporation’s Press Release by visiting: http://www.integrals.com/investor_relations/default.asp?c=101676&p=irol-newsArticle&ID=1004905&highlight 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 either online, by regular mail or by FAX.
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Updated May 31, 2007
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