Z-0262-2025 Class II Ongoing
FDA device recall Z-0262-2025 was initiated by Integra LifeSciences Corp. on September 26, 2024 and is designated Class II. Reason for recall: Out of specification endotoxin levels. The recall status is ongoing. Affected quantity: 128 units.
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