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XENMATRIX

Davol Inc. · Model 1161015 · UDI-DI 00801741031380

OWVOXHFTM Prescription
1
510(k) clearances
3
Adverse events
1
Recalls
11
Facilities

Description

XenMatrix Surgical Graft, 10 cm x 15 cm (3.9" x 5.9"), Rectangle

Recalls

DateFirmReason
2024-11-22Cook Biotech, Inc.Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.

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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.