Dural Graft Implants Recalled for Out-of-Specification Endotoxin Levels
Integra LifeSciences Corp. is recalling 128 units of Duraform Dural Graft Implant (Model 80-1477US, Lot CT007694) due to endotoxin levels exceeding specifications. No adverse events have been reported.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This recall meets Score 3 criteria as a risk-of-harm medical device (surgical implant) where injury has not yet been reported. The FDA Class II classification and absence of reported adverse events place it below the Score 4 threshold.
Plain-English summary
Integra LifeSciences Corp. is recalling 128 units of Duraform Dural Graft Implant, Size 3x3 (Model Number 80-1477US, Lot CT007694) due to out-of-specification endotoxin levels.
Endotoxins are bacterial byproducts that can trigger pyrogenic reactions and systemic inflammatory responses when present on medical implants. The recalled units were found to contain endotoxin levels exceeding acceptable specifications, which may pose a risk to patients receiving these implants.
The affected units were distributed to China. Product identification for the recalled lot is: Part# 80-1477US, Lot# CT007694, UDI# 10886704079477.
Patients and healthcare providers should contact Integra LifeSciences Corp. if they have or may have received this implant. No adverse events related to this recall have been reported.
The recalled product
- Product
- Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694
- Manufacturer
- Integra LifeSciences Corp.
- Hazard
- Affected units
- 128
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Part# 80-1477US Lot# CT007694 UDI# 10886704079477
Distribution
Distribution scope not specified by the agency.
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