Medical device recalls Moderate risk

Integra LifeSciences Corp. recalls Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694

Recall date
September 26, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0262-2025
FDA classification
Class II
Brand / firm
Integra LifeSciences Corp.
Sold / distributed
China

Why it was recalled

Out of specification endotoxin levels.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694

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