Z-0828-2007

EnDura No-React Dural Substitute 4 cm X 4 cm

Name: Z-0828-2007 EnDura No-React Dural Substitute 4 cm X 4 cm
Creator: Integra LifeSciences Corp.
Published: 2007-05-04
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2007-05-04 / Terminated / root cause: sterility

FDA source

Integra LifeSciences Corp. began a recall of EnDura No-React Dural Substitute 4 cm X 4 cm on 2007-05-04. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0828-2007
Status: Terminated
Initiated: 2007-05-04
Posted: 2007-05-24
Terminated: 2008-09-24
Recalling firm: Integra LifeSciences Corporation
Product: EnDura No-React Dural Substitute 4 cm X 4 cm.
Product code: DTZ Oxygenator, Cardiopulmonary Bypass
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
Root cause tag: sterility
FDA root cause: Other
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.
Quantity in commerce: 12,736 for all recalls Z-0827-0832-2007
Distribution: Nationwide Distribution to hospitals and medical centers
Product codes and lots: Product code: ENR20404: all lots

Product code DTZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)