Z-0451-2011

DuraGen XS Dural Regeneration Matrix: 3 inches x 3 inches. Non Pyrogenic; Rx only;Integra LifeSciences...

Name: Z-0451-2011 DuraGen XS Dural Regeneration Matrix: 3 inches x 3 inches. Non Pyrogenic; Rx only;Integra LifeSciences...
Creator: Integra LifeSciences Corp.
Published: 2010-09-29
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2010-09-29 / Terminated

FDA source

Integra LifeSciences Corp. began a recall of DuraGen XS Dural Regeneration Matrix: 3 inches x 3 inches. Non Pyrogenic; Rx only;Integra LifeSciences Corporation, Plainsboro, NJ 08536 USA DuraGen XS is... on 2010-09-29. The reason FDA records is "Test results no longer support a 3 year shelf life". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0451-2011
Status: Terminated
Initiated: 2010-09-29
Posted: 2010-11-24
Terminated: 2012-04-23
Recalling firm: Integra LifeSciences Corporation
Product: DuraGen XS Dural Regeneration Matrix: 3 inches x 3 inches. Non Pyrogenic; Rx only;Integra LifeSciences Corporation, Plainsboro, NJ 08536 USA DuraGen XS is indicated as a dural substitute for repair of dura matter.
Product code: GXQ Dura Substitute
Reason for recall: Test results no longer support a 3 year shelf life.
FDA root cause: Other
Action: Integra LifeSciences Corporation sent an URGENT Product Recall Notification letter dated September 29, 2010, to all affected customers. Integra NeruoSpecialists were informed of the recall via telephone conference call and recall notification letters sent by e-mail. Letters were also sent to customers by Federal Express with copies of e-mail provided to Interga Neuro Specialists on October 1, 2010. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately quarantine any affected product and contact Integra Customer Service at 1-800-654-2873, select option 5, followed by option 3. Customers were instructed to fill out and return the enclosed "Recall Acknowledgement and Return Form" indicating whether or not they possessed any of the affected product. For any questions related to this recall call 1-800-654-2873 and selection option 1.
Quantity in commerce: 1087
Distribution: Nationwide Distribution including AK, AL, AZ, CA, CO, DC, DE, FL, GA, HI, IL, IN, LA, MA, MD, ME, MN, MO, MT, NC, ND, NH, NJ, NM, NY, OK, PA, TN, TX, UT, VA, VT, WA, WI, AND WV.
Product codes and lots: Catalog number DXM1033, Lot number 1073337, 1080615, 1091090, 1092074, 1092192, 1095441, 1101582, 1101990.

Product code GXQ

K072207Class IIDuragen Xs Dural Regeneration MatrixIntegra Lifesciences Corp. / cleared 2007-08-23

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)