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Terminated

EnDura No-React Dural Substitute 5 cm x 6 cm

FDA Recall Z-0829-2007 · Posted 2007-05-24

Recalling FirmIntegra LifeSciences Corp.
Recall StatusTerminated
Date Initiated2007-05-04
Date Terminated2008-09-24
Product Quantity12,736 for all recalls Z-0827-0832-2007

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

Firm Action

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

Distribution Pattern

Nationwide Distribution to hospitals and medical centers

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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