products. The EnDura
products are manufactured by Shelhigh, Inc. ("Shelhigh") and distributed by
Integra. On April 18, 2007, the Food and Drug Administration ("FDA") issued
a Public Health Notification regarding products manufactured by Shelhigh,
citing sterility and other manufacturing concerns. FDA issued a letter to
Shelhigh on May 2, 2007 formally requesting that Shelhigh recall all its
medical devices remaining in the marketplace.
Integra is conducting a recall of all EnDura products
manufactured by Shelhigh and distributed by Integra to comply with FDA’s
request. Integra stopped shipping and quarantined all EnDura products on
April 18, 2007, the day FDA issued its Public Health Notification. On April
20, 2007, Integra notified hospitals by letter of Integra’s stop shipment of
EnDura products and FDA’s Public Health Notification. Following FDA’s May 2
letter to Shelhigh, Integra sent a letter on May 4, 2007 to hospitals
requesting the return of all EnDura products in their possession. On the
same day, Integra notified FDA regarding its recall plan.
The EnDura products are the only products manufactured by
Shelhigh that are distributed by Integra.
On May 18, 2007, FDA notified Integra that it had determined
that this recall action constitutes a Class I recall. A Class I recall is
the highest priority recall that is assigned when there is a reasonable
probability that use of or exposure to the product will cause serious
adverse health consequences or death.
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.
Only products in the EnDura™ No-React® Dural Substitute product line are
affected by this recall. No other products distributed by Integra are
included in this recall. The products affected by this recall are as
follows:
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 actions taken by Integra reflect the company’s
commitment to provide timely information to physicians, hospital facilities
and patients about the products it distributes. For additional information
about the recall of EnDura products, please contact Integra’s Customer
Service Department at (800) 456-8482.