FDA Medical Device Recalls (openFDA)
Integra LifeSciences Corp.: EnDura No React Dural Substitute 10 cm x 12 cm
- Recall number
- Z-0831-2007
- Recalling firm
- Integra LifeSciences Corp.
- Product
- EnDura No React Dural Substitute 10 cm x 12 cm
- Status
- Terminated
- Initiated
- 2007-05-04
- Posted
- 2007-05-24
- Terminated
- 2008-09-24
- Reason
- 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
- 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
- 12,736 for all recalls Z-0827-0832-2007
- Distribution
- Nationwide Distribution to hospitals and medical centers
- Lot, serial or model codes
- Product code: ENR21012: all lots
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DTZ
- Firm FEI
- 3003418325
- Firm city
- Plainsboro
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28