NeuraGen Nerve Guide NeuraGen Nerve Guide is indicated recall
NeuraGen Nerve Guide NeuraGen Nerve Guide is indicated for repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of…
Why was NeuraGen Nerve Guide NeuraGen Nerve Guide is indicated recalled?
Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
1105457 1112377, 1112378 1112103 1112106, 1112003, 1112296, 1110715 1112052, 1112004, 1112030 1111972 1112376
- Product
- NeuraGen Nerve Guide NeuraGen Nerve Guide is indicated for repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of…
- Recalling firm
- Integra LifeSciences Corporation
- Quantity
- 1,661 boxes
- Distribution
- Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.
- Recall date
- May 22, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)