CLASS II ONGOING Device recall · Reported 6 Nov 2024 · FDA Enforcement Report
Duraform Dural Graft Implant, Size recalled by Integra LifeSciences
Integra LifeSciences is recalling Duraform Dural Graft Implant, Size. The recall was initiated on 26 Sep 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0262-2025
- FDA event ID
- 95466
- Recalling firm
- Integra LifeSciences, Princeton, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 26 Sep 2024
- FDA classified
- 30 Oct 2024
- Reported
- 6 Nov 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Other Medical Devices
Timeline
| 26 Sep 2024 | Recall initiated by company | |
| 30 Oct 2024 | Classified by FDA | +34 days |
| 6 Nov 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Out of specification endotoxin levels.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694
Where it was distributed
China
Questions about this recall
Why was it recalled?
Out of specification endotoxin levels.
Which lots are affected?
Part# 80-1477US Lot# CT007694 UDI# 10886704079477
Where was it sold?
China
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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