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Axoguard HA+ Nerve Protector

AXOGEN CORPORATION · Model AGHA48 · UDI-DI 00850828007145

JXI Prescription

510(k) clearances

165

Adverse events

Recalls

Facilities

Description

Axoguard HA+ Nerve Protector is provided sterile, for single use only, and in a variety of sizes to meet the surgeon’s needs. K223640: Axoguard HA+ Nerve Protector is a surgical implant that provides non-constricting protection for non-transected peripheral nerve injuries. Axoguard HA+ Nerve Protector is designed to be an interface between the nerve and the surrounding tissue. Axoguard HA+ Nerve Protector is comprised of an extracellular matrix (ECM) and is fully remodeled during the healing process. When hydrated, Axoguard HA+ Nerve Protector is easy to handle, soft, pliable, nonfriable, and porous. The lubricant coating on Axoguard HA+ Nerve Protector is composed of sodium hyaluronate and sodium alginate. When hydrated, the lubricant coating reduces friction between the nerve and the surrounding tissue. Axoguard HA+ Nerve Protector is flexible to accommodate movement of the joint and associated tendons and has sufficient mechanical strength to hold sutures. K231708: Axoguard HA+ Nerve Protector is a surgical implant that provides non-constricting protection for peripheral nerve injuries. Axoguard HA+ Nerve Protector is designed to aid in coaptation and protection of peripheral nerve injuries by serving as an interface between the nerve and the surrounding tissue and also provides tension relief when used as a coaptation aid. Axoguard HA+ Nerve Protector is comprised of an extracellular matrix (ECM) and is fully remodeled during the healing process. When hydrated, Axoguard HA+ Nerve Protector is easy to handle, soft, pliable, nonfriable, and porous. The lubricant coating on Axoguard HA+ Nerve Protector is composed of sodium hyaluronate and sodium alginate. When hydrated, the lubricant coating reduces friction between the nerve and the surrounding tissue. Axoguard HA+ Nerve Protector is flexible to accommodate movement of the joint and has sufficient mechanical strength to hold sutures.

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.