FDASeptember 26, 2024device
Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Out of specification endotoxin levels.
What to do
FDA enforcement status: Ongoing
Brands named
integra lifesciencesintegra
UPCs
10886704079477
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDACytal Burn Matrix 10x15 cm. Product ID: BMM1015.2026-03-19
- FDACytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505.2026-03-19
- FDACytal Wound Matrix 2-Layer 7x10 cm. Product ID: WSM0710.2026-03-19
- FDACytal Burn Matrix 7x10 cm. Product ID: BMM0710.2026-03-19
- FDACytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015.2026-03-19
- FDACUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system.2026-03-06
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