Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694
FDA Recall #Z-0262-2025 — Class II — September 26, 2024
Product Description
Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694
Reason for Recall
Out of specification endotoxin levels.
Recalling Firm
Integra LifeSciences Corp. — Princeton, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
128 units
Distribution
China
Code Information
Part# 80-1477US Lot# CT007694 UDI# 10886704079477
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated