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Exactech, Inc.

134 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: recall (Z-1509-2026)Exactech, Inc.2026-03-09
Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT- recall (Z-1510-2026)Exactech, Inc.2026-03-09
Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog N recall (Z-0535-2026)Exactech, Inc.2025-11-17
Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog N recall (Z-0536-2026)Exactech, Inc.2025-11-17
Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter Model/Catalog Nu recall (Z-0537-2026)Exactech, Inc.2025-11-17
Exactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG PE 38MM HUM LIN recall (Z-2561-2025)Exactech, Inc.2025-09-12
Exactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 38MM HUM LINER + recall (Z-2562-2025)Exactech, Inc.2025-09-12
AcuMatch XLE Item Number / Product Description: 140-28-27 AM EHXL 0 LNR G 28MM 140-32-27 A recall (Z-1165-2025)Exactech, Inc.2025-02-12
Novation XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28- recall (Z-1166-2025)Exactech, Inc.2025-02-12
Alteon XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 recall (Z-1167-2025)Exactech, Inc.2025-02-12
Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers: a) 100-2 recall (Z-2236-2024)Exactech, Inc.2024-06-28
OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-0 recall (Z-2155-2024)Exactech, Inc.2024-06-18
OPTETRAK One Peg Patella,, Item Numbers: a) 200-03-26, 26MM; b) 200-03-29, 29MM; c) 200-03 recall (Z-2156-2024)Exactech, Inc.2024-06-18
OPTETRAK Inset Patella, Item Numbers: a) 200-05-23, 23MM; b) 200-05-26, 26MM; c) 200-05-29 recall (Z-2157-2024)Exactech, Inc.2024-06-18
OPTETRAK, Advanced Patella, 3 Peg Implant, Item Numbers: a) 200-07-26, 26MM; b) 200-07-29, recall (Z-2158-2024)Exactech, Inc.2024-06-18
Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, S recall (Z-1402-2024)Exactech, Inc.2024-03-29
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Si recall (Z-1403-2024)Exactech, Inc.2024-03-29
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Si recall (Z-1404-2024)Exactech, Inc.2024-03-29
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Smal recall (Z-1405-2024)Exactech, Inc.2024-03-29
Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, LEFT, Mates with: a) 38 recall (Z-1406-2024)Exactech, Inc.2024-03-29
Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with: a) 3 recall (Z-1407-2024)Exactech, Inc.2024-03-29
Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, LEFT, FOR CEMENTED USE ONLY, Mat recall (Z-1408-2024)Exactech, Inc.2024-03-29
Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, RIGHT, FOR CEMENTED USE ONLY, Ma recall (Z-1409-2024)Exactech, Inc.2024-03-29
Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, LEFT, FOR CEMENTED USE ONLY, Mat recall (Z-1410-2024)Exactech, Inc.2024-03-29
Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, RIGHT, FOR CEMENTED USE ONLY, Ma recall (Z-1411-2024)Exactech, Inc.2024-03-29
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, recall (Z-1412-2024)Exactech, Inc.2024-03-29
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, recall (Z-1413-2024)Exactech, Inc.2024-03-29
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 4 recall (Z-1414-2024)Exactech, Inc.2024-03-29
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, recall (Z-1415-2024)Exactech, Inc.2024-03-29
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) recall (Z-1416-2024)Exactech, Inc.2024-03-29
Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 32 recall (Z-1417-2024)Exactech, Inc.2024-03-29
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) recall (Z-1418-2024)Exactech, Inc.2024-03-29
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 32 recall (Z-1419-2024)Exactech, Inc.2024-03-29
Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthro recall (Z-1420-2024)Exactech, Inc.2024-03-29
Exactech Equinoxe Constrained Humeral Liner: Item Numbers: a) 320-40-10, b) 320-40-13, Sho recall (Z-1421-2024)Exactech, Inc.2024-03-29
Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) recall (Z-1422-2024)Exactech, Inc.2024-03-29
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 32 recall (Z-1423-2024)Exactech, Inc.2024-03-29
Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) recall (Z-1424-2024)Exactech, Inc.2024-03-29
Exactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, Item number 320 recall (Z-1425-2024)Exactech, Inc.2024-03-29
AcuMatch Hip System, Catalog Number 142-32-27 recall (Z-0577-2024)Exactech, Inc.2024-01-18
Exactech Alteon Hip XLE Liner, Catalog Numbers: a) 01-030-40-0636, b) 01-030-40-0640, c) 0 recall (Z-0578-2024)Exactech, Inc.2024-01-18
Exactech Equinoxe Reverse Shoulder System, Catalog Numbers: a) 320-36-00, b) 320-36-03, c) recall (Z-0579-2024)Exactech, Inc.2024-01-18
Exactech Equinoxe Shoulder System, Catalog Numbers: a) 314-23-02, b) 314-23-03, c) 314-23- recall (Z-0580-2024)Exactech, Inc.2024-01-18
Exactech Novation Hip System, Catalog Numbers: 134-36-45 recall (Z-0581-2024)Exactech, Inc.2024-01-18
Exactech Optetrak Knee System, Catalog Numbers: a) 200-02-26, b) 200-02-29, c) 200-02-32, recall (Z-0582-2024)Exactech, Inc.2024-01-18
Exactech Optetrak Logic Knee System, Catalog Numbers: a) 02-012-47-3011, b) 02-012-47-5009 recall (Z-0583-2024)Exactech, Inc.2024-01-18
Exactech Optetrak Logic PS Knee System, Catalog Numbers: 02-012-35-5009 recall (Z-0584-2024)Exactech, Inc.2024-01-18
Exactech Truliant Knee System, Catalog Numbers: a) 02-012-35-3509, b) 02-022-35-1509, c) 0 recall (Z-0585-2024)Exactech, Inc.2024-01-18
Exactech Truliant, Activit-E Knee Insert, Catalog Numbers: a) 02-023-02-0029, b) 02-023-02 recall (Z-0586-2024)Exactech, Inc.2024-01-18
Exactech Vantage Ankle System, Catalog Numbers: a) 350-21-04, b) 350-22-03 recall (Z-0587-2024)Exactech, Inc.2024-01-18
Exactech Vantage Mobile Bearing Tibial Inserts, Catalog Numbers: a) 350-41-23, b) 350-42-0 recall (Z-0588-2024)Exactech, Inc.2024-01-18
Exactech Shoulder GPS Impactor Handle, Catalog #531-07-05. recall (Z-2050-2023)Exactech, Inc.2023-06-30
Exactech Ergo Impactor Handle, Catalog #321-09-05. recall (Z-2051-2023)Exactech, Inc.2023-06-30
OPTETRAK Comprehensive Knee System, labeled as the following: a. OPTETRAK All-polyethylene recall (Z-0019-2022)Exactech, Inc.2021-10-04
OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Componen recall (Z-0020-2022)Exactech, Inc.2021-10-04
OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS recall (Z-0021-2022)Exactech, Inc.2021-10-04
OPTETRAK Comprehensive Knee System custom devices labeled as the following: a. CUSTOM OPTE recall (Z-0022-2022)Exactech, Inc.2021-10-04
TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. recall (Z-0023-2022)Exactech, Inc.2021-10-04
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component recall (Z-0024-2022)Exactech, Inc.2021-10-04
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Info recall (Z-0025-2022)Exactech, Inc.2021-10-04
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Prod recall (Z-0026-2022)Exactech, Inc.2021-10-04
ARTHROFOCUS Polyethylene Tibial Inserts (Product Line: 256-12-XX, 256-13-XX). NOTE: Inform recall (Z-0027-2022)Exactech, Inc.2021-10-04
Exactech BIOLOX delta Femoral Head, 36m O.D., REF 170-36-00. Hip prosthesis component. recall (Z-2250-2021)Exactech, Inc.2021-08-12
Exactech BIOLOX delta Femoral Head, 36m O.D. + 3.5mm, REF 170-36-03. Hip prosthesis compon recall (Z-2251-2021)Exactech, Inc.2021-08-12
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catal recall (Z-2112-2021)Exactech, Inc.2021-07-22
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catal recall (Z-2113-2021)Exactech, Inc.2021-07-22
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catal recall (Z-2114-2021)Exactech, Inc.2021-07-22
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catal recall (Z-2115-2021)Exactech, Inc.2021-07-22
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catal recall (Z-2116-2021)Exactech, Inc.2021-07-22
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catal recall (Z-2117-2021)Exactech, Inc.2021-07-22
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catal recall (Z-2118-2021)Exactech, Inc.2021-07-22
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catal recall (Z-2119-2021)Exactech, Inc.2021-07-22
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catal recall (Z-2120-2021)Exactech, Inc.2021-07-22
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catal recall (Z-2121-2021)Exactech, Inc.2021-07-22
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catal recall (Z-2122-2021)Exactech, Inc.2021-07-22
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catal recall (Z-2123-2021)Exactech, Inc.2021-07-22
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catal recall (Z-2124-2021)Exactech, Inc.2021-07-22
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catal recall (Z-2125-2021)Exactech, Inc.2021-07-22
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catal recall (Z-2126-2021)Exactech, Inc.2021-07-22
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catal recall (Z-2127-2021)Exactech, Inc.2021-07-22
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catal recall (Z-2128-2021)Exactech, Inc.2021-07-22
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catal recall (Z-2129-2021)Exactech, Inc.2021-07-22
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catal recall (Z-2130-2021)Exactech, Inc.2021-07-22
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catal recall (Z-2131-2021)Exactech, Inc.2021-07-22
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catal recall (Z-2132-2021)Exactech, Inc.2021-07-22
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catal recall (Z-2133-2021)Exactech, Inc.2021-07-22
Threaded Offset Cup Impactor - Product Usage: To assist the surgeon in the implantation of recall (Z-2499-2019)Exactech, Inc.2019-09-10
Equinoxe Cage, Glenoid, Alpha, Small Product Usage: The Equinoxe Shoulder System is indica recall (Z-0414-2018)Exactech, Inc.2018-01-18
Equinoxe Cage, Glenoid, Alpha, Medium Product Usage: The Equinoxe Shoulder System is indic recall (Z-0415-2018)Exactech, Inc.2018-01-18
Alteon HA Femoral Stem, Press-Fit, Extended Offset, Cementless, HA Coated, Collared, Size recall (Z-0538-2018)Exactech, Inc.2018-01-18
Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool recall (Z-0603-2018)Exactech, Inc.2018-01-18
Exactech 1.5" Novation Calcar Planer Guide Tip To assist the surgeon in the implantation o recall (Z-2644-2017)Exactech, Inc.2017-06-19
Logic Fit Tibial Tamp Head recall (Z-2662-2017)Exactech, Inc.2017-06-19
Exactech Optetrak Logic CC 15mm Tibial Augment Screws recall (Z-2704-2017)Exactech, Inc.2017-06-19
Exactech Acapella One Interbody Fusion Device Parallel. Orthopedic Spinal Surgery Device. recall (Z-0809-2016)Exactech, Inc.2016-02-13
Novation Element Press-Fit, Cementless, HA Coated, Collared, Standard Offset, Size 9, Femo recall (Z-0201-2016)Exactech, Inc.2015-11-02
Exactech Ambassador Cervical Plate System The Exactech Ambassador Cervical Place System is recall (Z-2070-2015)Exactech, Inc.2015-07-14
Exactech Single Barrel Drill Guides The Single Barrel Drill Guide is a nonpowered hand-hel recall (Z-2071-2015)Exactech, Inc.2015-07-14
Altiva / Exactech Spine, Large Set Screw, Catalog Number 28202, Lot Number AS05107. Intend recall (Z-2059-2015)Exactech, Inc.2015-07-10
Equinoxe 44mm Short Humeral Head Catalog Number 310-01-44. Orthopedic shoulder implant com recall (Z-1459-2015)Exactech, Inc.2015-04-20
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Every clearance here is in the API, with alerts when new ones post.