EnDura No-React Dural Substitute 12 cm Diameter

FDA device recall Z-0832-2007 · posted 2007-05-24 · Terminated

Recall details

Recalling firm

Integra LifeSciences Corp.

Reason for recall

Integra LifeSciences Corporation d/b/a Integra NeuroSciences, the distributor of EnDura No-React Dural Substitute, manufactured by Shelhigh, Inc., Union, NJ, is recalling this product based on an FDA Public Health Notification and FDA requested recall letter to Shelhigh citing sterility and other manufacturing concerns regarding this product manufactured by Shelhigh. Integra is a distributor of t

Action taken

On May 4, 2007, an Urgent Recall Notice and accompanying recall acknowledgement form was sent to all customers that had purchased or been supplied EnDura No-React Dural Substitute product since sale of the product was initiated in 2003. Recall Coordinators at each facility are asked to review inventory for EnDura products and to call Integra Customer Service for an authorization number for return of product.

Root cause

Other

Status

Terminated

Product code

DTZ

Quantity affected

12,736 for all recalls Z-0827-0832-2007

Distribution

Nationwide Distribution to hospitals and medical centers

Date initiated

2007-05-04

Date posted

2007-05-24

Date terminated

2008-09-24

Location

Plainsboro, NJ