Nerbridge®
TOYOBO CO., LTD. · Model RN04025E · UDI-DI 04965838907463
Description
Nerbridge® is a product composed of polyglycolic acid and collagen derived from porcine skin. Nerbridge® is a flexible, resorbable and semipermeable tubular membrane matrix filled with porous collagen that provides a non-constricting encasement for injured peripheral nerves for protection of the neural environment. Nerbridge® is designed to be an interface between the nerve and the surrounding tissue. When hydrated, Nerbridge® is an easy to handle, pliable, soft, non-friable, porous conduit. The resilience of Nerbridge® allows the product to recover and maintain closure without constricting the nerve once the device is placed around the nerve. Nerbridge® is manufactured using validated viral inactivation and removal processes for the collagen. The product is provided in a foil pouch, sterile, non-pyrogenic, for single use only, in a variety of sizes, and placed in an outer Tyvek header bag for added protection.
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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