Home › COOK BIOTECH INCORPORATED › AxoGuard

AxoGuard

COOK BIOTECH INCORPORATED · Model G52804 · UDI-DI 00827002528048

JXI Prescription

510(k) clearances

167

Adverse events

Recalls

Facilities

Description

AxoGuard Nerve Protector

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.