DURAFORM recallZ-0262-2025 · Integra LifeSciences Corp. · initiated Sep 26, 2024
Open, Classified
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
Out of specification endotoxin levels.
FDA root cause category: Nonconforming Material/Component
What the company is doing
An URGENT - FIELD SAFETY NOTICE dated 9/26/24 was sent to the customer. Actions to be Taken by Distributors: 1. If you do have the affected product listed in Table 1, remove the product from further distribution and place them in quarantine. 2. If you do have affected product, check the box on the enclosed form I do have affected product. 3. If you do not have affected product, check the box, I do not have affected product. 4. Complete the attached Distributor Reply Form in Appendix 1 and return to [email protected] or electronic FAX to 1-609-750-4220. 5. Keep a copy of the form for your records. 6. Please manage the returns with your customers per your process : credit can be provided if your customers have any product to return and they return it to you. 7. Forward a copy of the enclosed Field Safety Notice to any of your customers that have purchased the affected product. If you need a copy of a Customer Reply Form , use the one in Appendix 2, as applicable. PLEASE NOTE THAT REGARDLESS OF WHETHER YOU HAVE THE AFFECTED PRODUCT OR NOT A COMPLETED ACKNOWLEDGEMENT IS REQUIRED Finally, if required by the national medical device regulation of your distribution area, please ensure this Field Safety Corrective Action is notified to the national competent authorities. Thank you for your cooperation with this Field Safety Corrective Action and for returning the attached Reply Form. See return instructions on top of the reply forms in Appendix 1. Please feel free to contact our Post Market Surveillance Department at [email protected] for any additional questions.
Recall details
- Recall number
- Z-0262-2025
- Status
- Open, Classified
- Initiated by the company
- Sep 26, 2024
- Posted by the FDA
- Oct 30, 2024
- Recalling firm
- Integra LifeSciences Corp.
- Quantity
- 128 units
- Product code
- GXQ
- FDA submissions
- K152481
- Distribution
- China
Product description
Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694
Code information (models, lots, serial numbers)
Part# 80-1477US Lot# CT007694 UDI# 10886704079477
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- DURAFORM 80-1477USCerenovus, Inc. · DURA SUBSTITUTE1 recall0 reports
Product lines
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 16, 2026. Text above is shown as published by the FDA.
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