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Trigon

NVision Biomedical Technologies, Inc. · Model LMP-1731-0806 · UDI-DI 00810135962292

PLF HWC HRS Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

8mm Wedge 6° Transverse PEEK Large Multi Joint Lesser Metatarsal The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as: • Cotton (opening wedge) Osteotomies of the Medial Cuneiform • Evans Lengthening Osteotomies • Subtalar Fusion • First Metatarsal-Cuneiform Lengthening Arthrodesis • Calcaneocuboid Arthrodesis • Calcaneal Z Lengthening Osteotomies • MTP Lengthening Arthrodesis • Lesser Metatarsal-Cuneiform Lengthening Arthrodesis • Navicular-Cuneiform Arthrodesis • Talonavicular Arthrodesis The Trigon HA wedges are intended for use with ancillary fixation. The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.

Recalls

Date	Firm	Reason
2026-07-10	Paragon 28, Inc.	Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility.
2026-07-10	Paragon 28, Inc.	Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility.
2018-09-28	Paragon 28, Inc.	It has been determined that the wedge implant kit is permanently mislabeled with the wrong size. The wedge implant is a 10mm size and is permanently marked as a 12mm size. Use of t
2016-04-22	Arthrex, Inc.	Potential for polystyrene particulate presence.
2016-04-22	Arthrex, Inc.	Potential for polystyrene particulate presence.
2016-04-22	Arthrex, Inc.	Potential for polystyrene particulate presence.
2016-04-22	Arthrex, Inc.	Potential for polystyrene particulate presence.
2016-04-22	Arthrex, Inc.	Potential for polystyrene particulate presence.
2016-04-22	Arthrex, Inc.	Potential for polystyrene particulate presence.

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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.