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Arthrex Nerve Conduit

COLLAGEN MATRIX, INC. · Model ABS-3025C · UDI-DI 00813954027296

JXI Prescription
10
510(k) clearances
165
Adverse events
4
Recalls
38
Facilities

Description

Flexible Collagen Nerve Tube

Recalls

DateFirmReason
2023-03-27Baxter Healthcare CorporationThe product is brittle and potentially crumbling upon handling or when being removed from its package.
2020-02-07Integra LifeSciences Corp.Nonconforming product which was dispositioned for rejection was mistakenly released for commercial use.
2013-03-28Integra LifeSciences CorporationDue 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.
2013-03-28Integra LifeSciences CorporationDue 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.