FDA Enforcement
Class II
Ongoing
Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694
Recall: Z-0262-2025
·
Reported November 6, 2024
Enforcement
- Recall Number
- Z-0262-2025
- Event ID
- 95466
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Integra LifeSciences Corp.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 6, 2024
- Initiation Date
- September 26, 2024
- Classification Date
- October 30, 2024
- Address
- 1100 Campus Rd, N/A, Princeton, NJ, 08540-6650, United States
Description
Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694
Reason
Out of specification endotoxin levels.
Code Info
Part# 80-1477US Lot# CT007694 UDI# 10886704079477
Distribution
China
Quantity
128 units