Z-0588-04

EnDura No-React Dural Substitute. Product comes in different sizes (2x10, 4x4, 5x6, 6x10, 10x12, and 12 cm...

Name: Z-0588-04 EnDura No-React Dural Substitute. Product comes in different sizes (2x10, 4x4, 5x6, 6x10, 10x12, and 12 cm...
Creator: Shelhigh Inc
Published: 2003-12-19
License: https://open.fda.gov/license/

Shelhigh, Inc. / initiated 2003-12-19 / Terminated / root cause: sterility

FDA source

Shelhigh Inc began a recall of 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... on 2003-12-19. The reason FDA records is "The tamper-evident shrink band may fall off causing the user uncertainty whether the product was opened and is still sterile". 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-0588-04
Status: Terminated
Initiated: 2003-12-19
Posted: 2004-07-20
Terminated: 2006-04-06
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.
Product code: GXQ Dura Substitute
Reason for recall: The tamper-evident shrink band may fall off causing the user uncertainty whether the product was opened and is still sterile.
Root cause tag: sterility
FDA root cause: Other
Action: Letter was sent 12/19/2003 to the 19 hospitals were the product was distributed.
Quantity in commerce: 1002 units
Distribution: The product is distributed natiowide to 19 different hospitals.
Product codes and lots: 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.

Product code GXQ

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)