FDA Device recall Z-0262-2025
Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694
- FDA Device
- Class II
- ongoing
- Published 2024-11-06
On 2024-11-06 the FDA classified a Class II recall of Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694 by Integra Lifesciences, citing out of specification endotoxin levels.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0262-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-09-26 |
| Published | 2024-11-06 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Integra Lifesciences |
| Distribution | n/a |
Product
Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694
Reason
Out of specification endotoxin levels.
Identifiers
| code_info | Part# 80-1477US Lot# CT007694 UDI# 10886704079477 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0262-2025%22
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