FDA Medical Device Recalls (openFDA)
Shelhigh Inc: EnDura No-React Dural Substitute. Product comes in different sizes (2x10, 4x4, 5x6, 6x10, 10x12, and 12 cm diameters), sterile, stored in 2% benzyl alcohol, and distributed by Integra NeuroSciences, Plainsboro, NJ 08536.
- Recall number
- Z-0588-04
- Recalling firm
- Shelhigh Inc
- Product
- EnDura No-React Dural Substitute. Product comes in different sizes (2x10, 4x4, 5x6, 6x10, 10x12, and 12 cm diameters), sterile, stored in 2% benzyl alcohol, and distributed by Integra NeuroSciences, Plainsboro, NJ 08536.
- Status
- Terminated
- Initiated
- 2003-12-19
- Posted
- 2004-07-20
- Terminated
- 2006-04-06
- Reason
- The tamper-evident shrink band may fall off causing the user uncertainty whether the product was opened and is still sterile.
- Root cause
- Other
- Action
- Letter was sent 12/19/2003 to the 19 hospitals were the product was distributed.
- Quantity
- 1002 units
- Distribution
- The product is distributed natiowide to 19 different hospitals.
- Lot, serial or model codes
- Lot#, Catalog #, Description: 030911-NR, ENR-20210, 2CM X 10CM; 030911-NR, ENR-20404, 4CM X 4CM; 030911-NR, ENR-20506, 5CM X 6CM; 030808-NR, ENR-20610, 6CM X 10CM; 030811-NR, ENR-20610, 6CM X 10CM; 030911-NR, ENR-21012, 10CM X 12CM; 030924-NR, ENR-21012, 10CM X 12CM; 031027-NR, ENR-21212, 12CM Diameter.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GXQ
- Firm FEI
- 1000081147
- Firm city
- Union
- 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