FDA Medical Device Recalls (openFDA)
Integra LifeSciences Corp.: 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.
- Recall number
- Z-0451-2011
- Recalling firm
- Integra LifeSciences Corp.
- 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.
- Status
- Terminated
- Initiated
- 2010-09-29
- Posted
- 2010-11-24
- Terminated
- 2012-04-23
- Reason
- Test results no longer support a 3 year shelf life.
- 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
- 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.
- Lot, serial or model codes
- Catalog number DXM1033, Lot number 1073337, 1080615, 1091090, 1092074, 1092192, 1095441, 1101582, 1101990.
- 510(k) numbers
- ["K072207"]
- PMA numbers
- not on file
- Product code
- GXQ
- 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