Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Exactech and its 1 subsidiaries with 211 device recalls, 188 510(k) clearances and 2 warning letters. The most recent is a 510(k) clearance dated Apr 14, 2026: Equinoxe® Shoulder System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Exactech and its 1 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Apr 14, 2026 | Equinoxe® Shoulder SystemK260583 · PHX | 510(k) clearances |
| Feb 3, 2026 | Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05Class II · Impactor handle may be missing cross-pin | Device recalls |
| Feb 3, 2026 | Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311XClass II · Impactor handle may be missing cross-pin | Device recalls |
| Dec 19, 2025 | Warning letter: Process validation, Environmental monitoring, CAPACDRH | Warning letters |
| Dec 1, 2025 | Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsK250713 · KWT | 510(k) clearances |
| Sep 5, 2025 | Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: 321-59-46 Software Version: N/A ProductClass II · Due to products that have not completed design updates and performance testing being released/distributed. Products may | Device recalls |
| Sep 5, 2025 | Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter Model/Catalog Number: 301-11-11 Software Version: N/A Product Class II · Due to products that have not completed design updates and performance testing being released/distributed. Products may | Device recalls |
| Sep 5, 2025 | Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: 321-59-42 Software Version: N/A ProductClass II · Due to products that have not completed design updates and performance testing being released/distributed. Products may | Device recalls |
| Aug 15, 2025 | Exactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 38MM HUM LINER +0), REF: 322-38-03 (145-DEG PE 38MM HUM LINER +Class II · Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the l | Device recalls |
| Aug 15, 2025 | Exactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG PE 38MM HUM LINER +0/ 320-38-03,145-DEG PE 38MM HUM LINER +2.5Class II · Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the l | Device recalls |
| Aug 1, 2025 | Equinoxe® Shoulder SystemK243448 · PHX | 510(k) clearances |
| Jun 26, 2025 | Equinoxe® Scapula Fracture SystemK243275 · HRS | 510(k) clearances |
| Mar 10, 2025 | Alteon® HA Femoral StemsK243839 · MEH | 510(k) clearances |
| Dec 31, 2024 | AcuMatch XLE Item Number / Product Description: 140-28-27 AM EHXL 0¿ LNR G 28MM 140-32-27 AM EHXL 0¿ LNR G 32MM 140-32-28 AM EHXL 0¿ LNRClass II · Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer. | Device recalls |
| Oct 3, 2024 | Exactech® TRULIANT® Knee SystemK240393 · MBH | 510(k) clearances |
| Jul 18, 2024 | Equinoxe® Central Screw Baseplate SystemK233482 · PHX | 510(k) clearances |
| Jan 19, 2024 | Warning letter: CAPA, MDR reporting, Design controlsCDRH | Warning letters |
| Oct 12, 2023 | Exactech® Vantage® Total Ankle SystemK230717 · HSN | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
