Integra NeuraGen Nerve Guide Recalled for Pyrogen Deviation
Integra LifeSciences is recalling NeuraGen Nerve Guides because process deviations may have resulted in higher pyrogen levels than permitted.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations or specific injuries, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Integra LifeSciences Corporation is recalling 1,661 boxes of NeuraGen Nerve Guides. The product is indicated for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.
The recall was initiated due to a process deviation that may have resulted in product lots being released with higher levels of pyrogens than permitted by the product specifications.
The affected lots were distributed worldwide, including the United States (nationwide, including Puerto Rico) and numerous international locations. Healthcare providers and patients should stop using the recalled lots and contact the manufacturer for instructions.
The recalled product
- Product
- NeuraGen Nerve Guide NeuraGen Nerve Guide is indicated for repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.
- Manufacturer
- Integra LifeSciences Corporation
- Category
- Medical Device — Nerve Repair
- Hazard
- Affected units
- 1,661
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 (7)
- 1105457 1112377
- 1112378 1112103 1112106
- 1112003
- 1112296
- 1110715 1112052
- 1112004
- 1112030 1111972 1112376
Distribution
Part of a larger recall action
This product is one of 21 recalled by Integra LifeSciences Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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