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NeuroShield

Monarch Bioimplants GmbH · Model NS3020 · UDI-DI 07640181711017

JXI Prescription

510(k) clearances

167

Adverse events

Recalls

Facilities

Description

NeuroShield® is a chitosan polysaccharide film indicated for the repair of peripheral nerve injuries by providing a protective barrierduring tissue healing.

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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Data 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.