DuraGen Plus Dural Regeneration Matrix recallZ-1284-2013 · Integra LifeSciences Corporation · initiated Mar 28, 2013
Class II Terminated All recalls posted in May 2013
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Integra LifeSciences Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
FDA root cause category: Process control
What the company is doing
The firm, Integra, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated April 9, 2013, to all US, Canada, and non-EU Integra consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to verify if they have any lots of the listed product, if so, STOP using that product; remove the product from service; and promptly complete and return the PRODUCT RECALL RETURN ACKNOWLEDGMENT FORM via Email: [email protected] or FAX to : 1-609-275-9445. Customer Service department will contact you to return and replace the product. "However, if you have already implanted or used collagen sponge products affected by this recall, we recommend you monitor the patient for a fever in the immediate postoperative period according to the standard hospital or clinician protocol." For assistance or any other questions that you may have, please contact Customer Service at 1-855-532-1723.
Recall details
- Recall number
- Z-1284-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Mar 28, 2013
- Posted by the FDA
- May 10, 2013
- Recalling firm
- Integra LifeSciences Corporation
- Quantity
- 21,179 boxes
- Product code
- GXQ
- FDA submissions
- K032693
- Distribution
- Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.
Product description
DuraGen Plus Dural Regeneration Matrix DuraGen Plus Adhesion Barrier Matrix is an absorbable implant for repair and restoration of dural defects and as an adhesion barrier for the reduction of peridural fibrosis. DuraGen Plus matrix is an easy to handle, soft, white pliable, non-friable, porous, collagen matrix. DuraGen Plus matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes.
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
1125523, 1125517 1125522, 1125539 1125524, 1125525 1125526, 1125632 1125630, 1125678 1125679 1125677, 1125683 1125628, 1125813 1125814, 1125815 1125629, 1125520 1125521, 1125979 1126031, 1125980 1125981, 1125982 1126030, 1130243 1130071, 1130503 1130379, 1130381 1130384, 1130507 1130374, 1130380 1130382, 1130421 1130505, 1130424 1130654, 1130422 1130423, 1130428 1130639, 1130413 1130414, 1130383 1130425, 1130504 1130506, 1130426 1130427, 1130970 1130827, 1111606 1104879, 1110814 1111610, 1104876 1110815, 1111607 1110268, 1111360 1112339, 1104405 1104877, 1105455 1112008, 1112110 1112111, 1110845 1111940, 1112149 1104880, 1112148 1110244, 1110265 1110846, 1104878 1111609, 1111941 1104881, 1110812, 1110267, 1111359, 1112340, 1105307, 1111611, 1111939, 1112341, 1110266 1112146, 1112147
Other devices under the same FDA submission
5 devices cleared under K032693 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- DuraGen® Plus DP5013Integra Lifesciences Corporation · DURA SUBSTITUTE6 reports
- DuraGen® Plus DP1013Integra Lifesciences Corporation · DURA SUBSTITUTE3 reports
- DuraGen® Plus DP1045Integra Lifesciences Corporation · DURA SUBSTITUTE2 reports
- DuraGen® Plus DP1022Integra Lifesciences Corporation · DURA SUBSTITUTE1 report
- DuraGen® Plus DP1033Integra Lifesciences Corporation · DURA SUBSTITUTE1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 64778).
- Z-1282-2013 · TerminatedDural Graft Matrix DuraGen Dural Graft Matrix is an absorbable implant for repair of dural defects. DuraGen matrix is an easy to handle, soft, white, pliable, nonfriable, porous …
- Z-1283-2013 · TerminatedSuturable DuraGen Dural Regenerative Matrix Suturable DuraGen Dural Regenerative Matrix is an absorbable implant for repair of dural defects. Suturable DuraGen is an easy to handl…
- Z-1286-2013 · TerminatedNeuraWrap Nerve Protector NeuraWrap Nerve Protector is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.
- Z-1287-2013 · TerminatedNeuraGen Nerve Guide NeuraGen Nerve Guide is indicated for repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page