Z-0262-2025 Class II Ongoing

Recalled by Integra LifeSciences Corp. — Princeton, NJ

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