FDA-Device2024-11-06Class II

Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694

Integra LifeSciences Corp.
Hazard

Out of specification endotoxin levels.

Sold states
China
Affected count
128 units
Manufactured in
1100 Campus Rd, N/A, Princeton, NJ, United States
Products
Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0262-2025

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