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Phasix

Davol Inc. · Model 1213035 · UDI-DI 00801741161308

OOD ORQ GCJ FTL OWT Prescription

510(k) clearances

1,255

Adverse events (7 deaths)

Recalls

Facilities

Description

Phasix ST Mesh with Echo 2 Positioning System, 30 cm x 35 cm (12" x 14"), Ellipse

Recalls

Date	Firm	Reason
2016-11-21	Tepha Incorporated	Endotoxin values from testing of retains slightly exceeded the established specification.

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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.