Device product
Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694
Z-0262-2025
Product summary
- Event
- Event 95466
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 128 units
- Official record key
device-enforcement:Z-0262-2025
Official wording
Reason: Out of specification endotoxin levels.
Code information: Part# 80-1477US Lot# CT007694 UDI# 10886704079477
Distribution pattern: China
Derived failure modes
-
Potency or specification failure
Out of specification