Reported Nov 6, 2024 · Ongoing
Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694
Integra LifeSciences Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Integra LifeSciences Corp. · 1100 Campus Rd · Princeton, NJ · 08540-6650
Is this the product you have?
Duraform Dural Graft ImplantSize 3x3Model Number 80-1477US Lot CT007694
- Lot codes and dates
- Part# 80-1477US Lot# CT007694 UDI# 10886704079477
- Amount recalled
- 128 units
This recall covers 23 products
The agency filed one notice per product. You are reading one of them; the other 22 are below.
10 more are in the archive.
Why it was recalled
Out of specification endotoxin levels.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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