Class II
Medical Device Recall: Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694
Integra LifeSciences Corp. · September 26, 2024
Reason for Recall
Out of specification endotoxin levels.
Distribution
China
Quantity Affected
128 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0262-2025
Status: ongoing
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