Home › NVision Biomedical Technologies, Inc. › Trigon
Trigon
NVision Biomedical Technologies, Inc. · Model COP-16-16-07 · UDI-DI 00810005667906
PLF
Prescription
1
510(k) clearances
25
Adverse events
9
Recalls
40
Facilities
Description
Implant: 16mm x 16mm x 7mm Cotton PEEK HA Wedge. The Trigon HA Stand-Alone Wedge Fixation System is a family of wedges used for angular correction of small bones of the foot. The HA PEEK wedges w/ tantalum markers are provided in multiple footprint and thickness designs, and the titanium bone screws are available in multiple lengths to accommodate variations in patient anatomy.
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. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.