FDA Device recall Z-1287-2013
NeuraGen Nerve Guide NeuraGen Nerve Guide is indicated for repair of peripheral nerve discontinuities where gap closure can be achieved by…
- FDA Device
- Class II
- terminated
- Published 2013-05-22
On 2013-05-22 the FDA classified a Class II recall of NeuraGen Nerve Guide NeuraGen Nerve Guide is indicated for repair of peripheral nerve discontinuities where gap closure can be achieved by… by Integra Lifesciences, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1287-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-03-28 |
| Published | 2013-05-22 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Integra Lifesciences |
| Distribution | US |
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.
Reason
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.
Identifiers
| code_info | 1105457 1112377, 1112378 1112103 1112106, 1112003, 1112296, 1110715 1112052, 1112004, 1112030 1111972 1112376 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1287-2013%22
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