Z-0262-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 6, 2024
- Initiation Date
- September 26, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 128 units
Product Description
Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694
Reason for Recall
Out of specification endotoxin levels.
Distribution Pattern
China
Code Information
Part# 80-1477US Lot# CT007694 UDI# 10886704079477