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Trigon
NVision Biomedical Technologies, Inc. · Model LDP-2405-0010 · UDI-DI 00810005667166
1
510(k) clearances
23
Adverse events
9
Recalls
38
Facilities
Description
5mm (0° Sagittal 10° Transverse) PEEK Lapidus Wedge . 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 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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Get your free API keyRead the docsData 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.