Exactech, Inc.
Exactech, Inc. appears in FDA public data with 211 recalls, 186 510(k) clearances, 14 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-1509-2026, Class II) was initiated on February 3, 2026. Its most recent 510(k) clearance was granted on April 14, 2026.
Summary
- Total Recalls
- 211
- 510(k) Clearances
- 186
- Inspections
- 14
- Compliance Actions
- 1
Known Names
exactech, exactech sarasota
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1509-2026 | Class II | Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09- | February 3, 2026 |
| Z-1510-2026 | Class II | Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311X | February 3, 2026 |
| Z-0536-2026 | Class II | Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: 3 | September 5, 2025 |
| Z-0537-2026 | Class II | Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter Model/Catalog Number: 30 | September 5, 2025 |
| Z-0535-2026 | Class II | Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: 3 | September 5, 2025 |
| Z-2562-2025 | Class II | Exactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 38MM HUM LINER +0), REF | August 15, 2025 |
| Z-2561-2025 | Class II | Exactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG PE 38MM HUM LINER +0/ | August 15, 2025 |
| Z-1167-2025 | Class II | Alteon XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV E | December 31, 2024 |
| Z-1165-2025 | Class II | AcuMatch XLE Item Number / Product Description: 140-28-27 AM EHXL 0¿ LNR G 28MM 140-32-27 AM EHXL | December 31, 2024 |
| Z-1166-2025 | Class II | Novation XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV E | December 31, 2024 |
| Z-2236-2024 | Class II | Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers: a) 100-22-19, | April 26, 2024 |
| Z-2156-2024 | Class II | OPTETRAK One Peg Patella,, Item Numbers: a) 200-03-26, 26MM; b) 200-03-29, 29MM; c) 200-03-32 | April 18, 2024 |
| Z-2158-2024 | Class II | OPTETRAK, Advanced Patella, 3 Peg Implant, Item Numbers: a) 200-07-26, 26MM; b) 200-07-29, 29MM | April 18, 2024 |
| Z-2155-2024 | Class II | OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-3 | April 18, 2024 |
| Z-2157-2024 | Class II | OPTETRAK Inset Patella, Item Numbers: a) 200-05-23, 23MM; b) 200-05-26, 26MM; c) 200-05-29 | April 18, 2024 |
| Z-1415-2024 | Class II | Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 | March 6, 2024 |
| Z-1405-2024 | Class II | Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item | March 6, 2024 |
| Z-1413-2024 | Class II | Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, | March 6, 2024 |
| Z-1416-2024 | Class II | Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, | March 6, 2024 |
| Z-1410-2024 | Class II | Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, LEFT, FOR CEMENTED USE ONLY, Mates with: | March 6, 2024 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K260583 | Equinoxe® Shoulder System | April 14, 2026 |
| K250713 | Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants | December 1, 2025 |
| K243448 | Equinoxe® Shoulder System | August 1, 2025 |
| K243275 | Equinoxe® Scapula Fracture System | June 26, 2025 |
| K243839 | Alteon® HA Femoral Stems | March 10, 2025 |
| K240393 | Exactech® TRULIANT® Knee System | October 3, 2024 |
| K233482 | Equinoxe® Central Screw Baseplate System | July 18, 2024 |
| K230717 | Exactech® Vantage® Total Ankle System | October 12, 2023 |
| K223933 | Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws | September 25, 2023 |
| K223833 | Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays | September 14, 2023 |
| K232002 | Vantage® Total Ankle System | September 11, 2023 |
| K223252 | TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX Patellas | July 17, 2023 |
| K221323 | Exactech® Alteon® Short Tapered Wedge | May 19, 2023 |
| K212356 | Exactech® Equinoxe® Laser Cage Glenoid | March 4, 2022 |
| K192097 | Exactech® Equinoxe® Stemless Humeral Components | April 29, 2020 |
| K193098 | Exactech® Equinoxe® Reverse Shoulder Glenospheres | February 20, 2020 |
| K190890 | Exactech Alteon Modular Dual Mobility (MDM) System | October 22, 2019 |
| K191561 | Exactech Equinoxe Humeral Augmented Trays | August 20, 2019 |
| K183343 | Vantage Total Ankle Flat Cut Talar Components | April 1, 2019 |
| K182502 | Alteon Acetabular Cup System | March 13, 2019 |