On May 25, 2007, Integra LifeSciences announced a recall of products in its EnDura No-React Dural Substitute product line. The products, manufactured by Shelhigh, Inc. and distributed by Integra, may present sterility and other manufacturing concerns.

The Food and Drug Administration (FDA) categorized the recall as Class I, which is assigned when a reasonable probability that use of or exposure to a product will cause serious adverse health effects or even death.

Integra is recalling all EnDura products shipped after 2003 that may still be in the marketplace. On April 18, 2007, the company stopped shipping and quarantined all EnDura products, then notified hospitals by letter two days letter. On May 4, 2007, Integra sent letters to hospitals requesting the return of all EnDura products and notified the FDA of its recall plan.

The Endura products included in the recall are:

• EnDura™ No-React® Dural Substitute 2cm x 10 cm
• EnDura™ No-React® Dural Substitute 4cm x 4 cm
• EnDura™ No-React® Dural Substitute 5cm x 6cm
• EnDura™ No-React® Dural Substitute 6cm x 10cm
• EnDura™ No-React® Dural Substitute 10cm x 12cm
• EnDura™ No-React® Dural Substitute 12cm Diameter

Source: “Integra LifeSciences EnDura No-React Dural Substitute,” Food and Drug Administration Safety Information Alert, May 25, 2007.