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NervAlign Nerve Cuff
RENERVE LIMITED · Model NA-NC2030 · UDI-DI 09369998146796
JXI
Prescription
1
510(k) clearances
167
Adverse events
4
Recalls
38
Facilities
Description
An absorbable collagen membrane implant that provides non-constricting protection for peripheral nerves. It is designed to be an interface between the nerve and the surrounding tissue and used for the repair of peripheral nerves in which there is no gap or where a gap closure is achieved by flexion of the extremity.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-03-27 | Baxter Healthcare Corporation | The product is brittle and potentially crumbling upon handling or when being removed from its package. |
| 2020-02-07 | Integra LifeSciences Corp. | Nonconforming product which was dispositioned for rejection was mistakenly released for commercial use. |
| 2013-03-28 | Integra LifeSciences Corporation | 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. |
| 2013-03-28 | Integra LifeSciences Corporation | 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. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.