FDA recall Z-0262-2025
Integra LifeSciences Corp. · Class II · device
Product
Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694
Reason for recall
Out of specification endotoxin levels.
Distribution
China
Key facts
- Status
- Ongoing
- Initiation date
- 2024-09-26
- Report date
- 2024-11-06
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Princeton, NJ, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0262-2025