Recall archive / FDA device enforcement
Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694 — FDA record Z-0262-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Sep 26, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694
- Reason
- Out of specification endotoxin levels.
- Classification
- Class II
- Recalling firm
- Integra LifeSciences Corp.
- Quantity
- 128 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0262-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Part# 80-1477US Lot# CT007694 UDI# 10886704079477 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
China
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Nov 6, 2024
- Recall initiation date
- Sep 26, 2024
- Center classification date
- Oct 30, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.