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GalaFLEX 3D

Tepha, Inc. · Model 100042-10 · UDI-DI 00810054980353

OOD Prescription

510(k) clearances

1,213

Adverse events (7 deaths)

Recalls

Facilities

Description

GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold.

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.