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U.S. Department of Health and Human Services

Safety

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Integra LifeSciences EnDura No-React Dural Substitute

Audience: Hospital Administrators, hospital risk managers, healthcare professionals, patients

[UPDATE 05/31/2007] Recall classified by FDA as Class I.

[Posted 05/25/2007] Integra LifeSciences (Integra) informed healthcare professionals and patients of a recall of all EnDura No-React Dural Substitute (EnDura) products. The products are manufactured by Shelhigh, Inc. and distributed by Integra. The recall is pursuant to an April 18, 2007, FDA Public Health Notification regarding products manufactured by Shelhigh, citing sterility and other manufacturing concerns and FDA's request that Shelhigh recall all of its medical devices remaining in the marketplace. Integra is recalling all Endura products that may be in the field from the date of the first shipment by Integra in 2003 to present. On May 18, 2007, FDA classified the recall as Class I. A Class I recall is assigned when there is a reasonable probability that use of or exposure to a product will cause serious adverse health consequences or death. See the attached manufacturer's press release for a list of products affected by this recall.

[May 31, 2007 - Recall Notice - FDA]
[May 25, 2007 - News Release (PDF) - Integra LifeSciences]