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Alyte™ Y-Mesh Graft

C. R. Bard, Inc. · Model Y100 · UDI-DI 00801741016158

OTO Prescription
10
510(k) clearances
4,773
Adverse events (24 deaths)
1
Recalls
20
Facilities

Description

Alyte™ Y-Mesh Graft

Recalls

DateFirmReason
2013-04-12Coloplast Manufacturing US, LLCColoplast is recalling one lot of Restorelle L prosthesis because it is mislabeled. The incorrect Instructions For Use (IFU) pamphlet is included in the packaging.

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

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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.