FDAFDA · Food and drugs·Recall number Z-0262-2025
Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694
Published November 6, 2024 · Recall initiated: September 26, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Out of specification endotoxin levels.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Integra LifeSciences Corp.
- Distributor
- China
- Lot
- Part# 80-1477US Lot# CT007694 UDI# 10886704079477
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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