Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Duraform Dural Graft Implant Recalled by Integra LifeSciences Corp. Due to Out of specification endotoxin levels.

Date: September 26, 2024
Company: Integra LifeSciences Corp.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Integra LifeSciences Corp. directly.

Affected Products

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

Quantity: 128 units

Why Was This Recalled?

Out of specification endotoxin levels.

Where Was This Sold?

China

About Integra LifeSciences Corp.

Integra LifeSciences Corp. has 216 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report