Suturable DuraGen Dural Regeneration Matrix recallZ-1081-2010 · Integra LifeSciences Corp · initiated Jan 13, 2010
Terminated All recalls posted in March 2010
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 Corp 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
One lot of Suturable DuraGen Dural Regeneration Matrix (# 1091575) did not pass stability testing at certain time points for Suture Retention Strength and Shrink Temperature specifications.
FDA root cause category: Other
What the company is doing
An "URGENT PRODUCT RECALL NOTIFICATION" dated January 13, 2010, was sent via Federal Express to customers. The notification described the product, problem, hazard involved and action to be taken by customers. In the event that the customers have in their possession any products from the specific lot number 1091576, the customers are being ask to please immediately quarantine all stock on hand and contact their local Integra Sales representative for further assistance and for arrangements of product return. The customers are being ask to return the enclosed "Recall Acknowledge and Return Form" indicating whether or not they possess any of the affected product identified. Integra will replace any product affected by this Recall that is returned. Please feel free to contact me at 609-936-5407 should you have any additional questions.
Recall details
- Recall number
- Z-1081-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jan 13, 2010
- Posted by the FDA
- Mar 11, 2010
- Recalling firm
- Integra LifeSciences Corp
- Quantity
- 94
- Product code
- GXQ
- FDA submissions
- K043427
- Distribution
- Nationwide distribution:Ca, NY, TX, CO, VA, SC, IA, MO, IL, LA, OR, OH, WI, FL, DC, DE, MD, MN.
Product description
Suturable DuraGen Dural Regeneration Matrix; Non-Pyrogenic; Sterility guaranteed unless package is damaged or opened. Rx only. Manufacturer: Integra LifeSciences Corporation, Plainsboro, NJ 08536 Suturable DuraGen is an absorbable implant for repair of dural defects. It is indicated as a dural substitute for the repair of dura matter.
Code information (models, lots, serial numbers)
Catalog Number DURS3391; Lot number 1091575
Other devices under the same FDA submission
3 devices cleared under K043427 — 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® Suturable DURS2291Integra Lifesciences Corporation · DURA SUBSTITUTE5 reports
- DuraGen® Suturable DURS3391Integra Lifesciences Corporation · DURA SUBSTITUTE3 reports
- DuraGen® Suturable DURS1391Integra Lifesciences Corporation · DURA SUBSTITUTE2 reports
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.
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