Exactech, Inc.

FDA Regulatory Profile

Summary

Total Recalls
211
510(k) Clearances
185
Inspections
14
Compliance Actions
1

Known Names

exactech, exactech sarasota

Recent Recalls

NumberClassProductDate
Z-1509-2026Class IIBrand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-February 3, 2026
Z-1510-2026Class IIBrand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311XFebruary 3, 2026
Z-0537-2026Class IIBrand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter Model/Catalog Number: 30September 5, 2025
Z-0535-2026Class IIBrand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: 3September 5, 2025
Z-0536-2026Class IIBrand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: 3September 5, 2025
Z-2562-2025Class IIExactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 38MM HUM LINER +0), REFAugust 15, 2025
Z-2561-2025Class IIExactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG PE 38MM HUM LINER +0/ August 15, 2025
Z-1167-2025Class IIAlteon XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV EDecember 31, 2024
Z-1165-2025Class IIAcuMatch XLE Item Number / Product Description: 140-28-27 AM EHXL 0¿ LNR G 28MM 140-32-27 AM EHXLDecember 31, 2024
Z-1166-2025Class IINovation XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV EDecember 31, 2024
Z-2236-2024Class IIAcumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers: a) 100-22-19,April 26, 2024
Z-2156-2024Class IIOPTETRAK One Peg Patella,, Item Numbers: a) 200-03-26, 26MM; b) 200-03-29, 29MM; c) 200-03-32April 18, 2024
Z-2157-2024Class IIOPTETRAK Inset Patella, Item Numbers: a) 200-05-23, 23MM; b) 200-05-26, 26MM; c) 200-05-29April 18, 2024
Z-2155-2024Class IIOPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-3April 18, 2024
Z-2158-2024Class IIOPTETRAK, Advanced Patella, 3 Peg Implant, Item Numbers: a) 200-07-26, 26MM; b) 200-07-29, 29MMApril 18, 2024
Z-1402-2024Class IIExactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), March 6, 2024
Z-1405-2024Class IIExactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, ItemMarch 6, 2024
Z-1415-2024Class IIExactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 March 6, 2024
Z-1425-2024Class IIExactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, Item number 320-46-10, b)March 6, 2024
Z-1424-2024Class IIExactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, ItMarch 6, 2024

Recent 510(k) Clearances

K-NumberDeviceDate
K250713Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsDecember 1, 2025
K243448Equinoxe® Shoulder SystemAugust 1, 2025
K243275Equinoxe® Scapula Fracture SystemJune 26, 2025
K243839Alteon® HA Femoral StemsMarch 10, 2025
K240393Exactech® TRULIANT® Knee SystemOctober 3, 2024
K233482Equinoxe® Central Screw Baseplate SystemJuly 18, 2024
K230717Exactech® Vantage® Total Ankle SystemOctober 12, 2023
K223933Exactech Equinoxe PHx Fracture System; Exactech EPIC ScrewsSeptember 25, 2023
K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysSeptember 14, 2023
K232002Vantage® Total Ankle SystemSeptember 11, 2023
K223252TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX PatellasJuly 17, 2023
K221323Exactech® Alteon® Short Tapered WedgeMay 19, 2023
K212356Exactech® Equinoxe® Laser Cage GlenoidMarch 4, 2022
K192097Exactech® Equinoxe® Stemless Humeral ComponentsApril 29, 2020
K193098Exactech® Equinoxe® Reverse Shoulder GlenospheresFebruary 20, 2020
K190890Exactech Alteon Modular Dual Mobility (MDM) SystemOctober 22, 2019
K191561Exactech Equinoxe Humeral Augmented TraysAugust 20, 2019
K183343Vantage Total Ankle Flat Cut Talar ComponentsApril 1, 2019
K182502Alteon Acetabular Cup SystemMarch 13, 2019
K182346TRULIANT Porous Tibial Tray and Exactech Alteon Bone ScrewsNovember 26, 2018