FDA Medical devices recall ·
Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US recall
- Recall number
- Z-0262-2025
- Date
- (initiated September 26, 2024)
- Company / brand
- Integra LifeSciences Corp.
1100 Campus Rd, Princeton, NJ, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 128 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694
Why was it recalled?
Out of specification endotoxin levels.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Part# 80-1477US Lot# CT007694 UDI# 10886704079477
Distribution
China
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0262-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.