Home › SYNOVIS MICRO COMPANIES ALLIANCE, INC › Neurotube

Neurotube

SYNOVIS MICRO COMPANIES ALLIANCE, INC · Model GEM0240NT · UDI-DI 00844735006186

JXI Prescription

510(k) clearances

167

Adverse events

Recalls

Facilities

Description

The NEUROTUBE device Absorbable Woven Polyglycolic Acid Mesh Tube is designed for primary or secondary peripheral nerve repair or reconstruction.

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.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

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.