Duraform Dural Graft Implant recall: Endotoxin
Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694
Why was Duraform Dural Graft Implant recalled?
Out of specification endotoxin levels.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Part# 80-1477US Lot# CT007694 UDI# 10886704079477
- Product
- Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694
- Recalling firm
- Integra LifeSciences Corp.
- Quantity
- 128 units
- Distribution
- China
- Recall date
- November 6, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)