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 Implant
    • Size 3x3
    • Model 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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:53 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.