Recalls / —

—#210341

Product

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

FDA product code

GXQ — Dura Substitute

Device class

Class 2

Medical specialty

Neurology

510(k) numbers

K152481

Affected lot / code info

Part# 80-1477US Lot# CT007694 UDI# 10886704079477

Why it was recalled

Out of specification endotoxin levels.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm

Integra LifeSciences Corp.

Address

1100 Campus Rd, Princeton, New Jersey 08540-6650

Distribution

Distribution pattern

China

Timeline

Recall initiated

2024-09-26

Posted by FDA

2024-10-30

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #210341. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.