FDA Medical Device Recalls (openFDA)
Integra LifeSciences Corp.: Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694
- Recall number
- Z-0262-2025
- Recalling firm
- Integra LifeSciences Corp.
- Product
- Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694
- Status
- Open, Classified
- Initiated
- 2024-09-26
- Posted
- 2024-10-30
- Terminated
- not on file
- Reason
- Out of specification endotoxin levels.
- Root cause
- Nonconforming Material/Component
- Action
- 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 FCA1@integralife.com 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 FCA1@integralife.com for any additional questions.
- Quantity
- 128 units
- Distribution
- China
- Lot, serial or model codes
- Part# 80-1477US Lot# CT007694 UDI# 10886704079477
- 510(k) numbers
- ["K152481"]
- PMA numbers
- not on file
- Product code
- GXQ
- Firm FEI
- 3003418325
- Firm city
- Princeton
- 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