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GalaFORM 3D

Tepha, Inc. · Model 100043-12 · UDI-DI 00855920006331

OOD Prescription

510(k) clearances

1,213

Adverse events (7 deaths)

Recalls

Facilities

Description

GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured 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. The scaffold has a 3D curvature supported with a P4HB rim designed to promote better conformance with a patient's anatomy in locations in which a flat design does not easily conform. P4HB bioresorbs through a process of hydrolysis and hydrolytic enzymatic digestion. It has been developed to optimize resorption rate and prolong strength retention in order to provide support throughout the expected period of healing. Although the scaffold loses strength with time, its porous construction was designed to allow native tissue ingrowth and gradual transfer of load from the scaffold to the tissue. Pre-clinical implantation studies indicate that GalaFORM 3D scaffold retains approximately 70% of its strength at 12 weeks. Bioresorption of the scaffold material will be essentially complete within 18-24 months.

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.