Z-0262-2025Class II

Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694

Name: Z-0262-2025 Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694
Creator: Integra LifeSciences Corp.
Published: 2024-09-26
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2024-09-26 / Open, Classified / root cause: manufacturing process

FDA source

Integra LifeSciences Corp. began a recall of Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694 on 2024-09-26. FDA classified it as Class II and gives the reason as "Out of specification endotoxin levels". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0262-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-09-26
Posted: 2024-10-30
Recalling firm: Integra LifeSciences Corporation
Product: Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694
Product code: GXQ Dura Substitute
Reason for recall: Out of specification endotoxin levels.
Root cause tag: manufacturing process
FDA 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 [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.
Quantity in commerce: 128 units
Distribution: China
Product codes and lots: Part# 80-1477US Lot# CT007694 UDI# 10886704079477

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0262-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0262-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-06	2024-10-30

Product code GXQ

K152481Class IIDURAFORM Dural Graft ImplantCodman & Shurtleff, Inc. / cleared 2015-10-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)