Brand

Exactech, Inc. Recalls

136 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Exactech, Inc..

136Total Recalls
0Critical
2.4MUnits Affected
Feb 3, 2026Most Recent
All Recalls

Every Exactech, Inc. Recall

Sorted by most recent. Click any recall for full details.

136 recalls
High RiskFDA
Exactech, Inc.
Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05
Medical Devices·120 affected·Feb 3, 2026
High RiskFDA
Exactech, Inc.
Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: 321-59-46 Software Version: N/A Prod...
Medical Devices·1 affected·Sep 5, 2025
High RiskFDA
Exactech, Inc.
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 LINE...
Medical Devices·11,542 affected·Aug 15, 2025
High RiskFDA
Exactech, Inc.
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¿ ...
Medical Implants·42 affected·Dec 31, 2024
High RiskFDA
Exactech, Inc.
OPTETRAK Inset Patella, Item Numbers: a) 200-05-23, 23MM; b) 200-05-26, 26MM; c) 200-05-29, 29MM
Medical Devices·0 affected·Apr 18, 2024
High RiskFDA
Exactech, Inc.
OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-32, 32MM; d) 200-02-35, 35MM; e) 2...
Medical Devices·0 affected·Apr 18, 2024
High RiskFDA
Exactech, Inc.
Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, RIGHT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Ite...
Medical Devices·39 affected·Mar 6, 2024
High RiskFDA
Exactech, Inc.
Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-0...
Medical Devices·985 affected·Mar 6, 2024
High RiskFDA
Exactech, Inc.
Exactech Equinoxe Constrained Humeral Liner: Item Numbers: a) 320-40-10, b) 320-40-13, Shoulder Arthroplasty
Medical Devices·447 affected·Mar 6, 2024
High RiskFDA
Exactech, Inc.
Exactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, Item number 320-46-10, b) +2.5mm, Item Number 320-46-13; Shoul...
Medical Devices·591 affected·Mar 6, 2024
High RiskFDA
Exactech, Inc.
Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty
Medical Devices·2,806 affected·Mar 6, 2024
High RiskFDA
Exactech, Inc.
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, ...
Medical Devices·12,643 affected·Mar 6, 2024
High RiskFDA
Exactech, Inc.
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, ...
Medical Devices·4,007 affected·Mar 6, 2024
High RiskFDA
Exactech, Inc.
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Nu...
Medical Devices·6,840 affected·Mar 6, 2024
High RiskFDA
Exactech, Inc.
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium...
Medical Devices·6,678 affected·Mar 6, 2024
High RiskFDA
Exactech, Inc.
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13,...
Medical Devices·7,213 affected·Mar 6, 2024
High RiskFDA
Exactech, Inc.
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium...
Medical Devices·2,008 affected·Mar 6, 2024
High RiskFDA
Exactech, Inc.
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arth...
Medical Devices·11,863 affected·Mar 6, 2024
High RiskFDA
Exactech, Inc.
Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, LEFT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item...
Medical Devices·35 affected·Mar 6, 2024
High RiskFDA
Exactech, Inc.
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, ...
Medical Devices·3,436 affected·Mar 6, 2024
High RiskFDA
Exactech, Inc.
AcuMatch Hip System, Catalog Number 142-32-27
Medical Devices·0 affected·Nov 21, 2023
High RiskFDA
Exactech, Inc.
Exactech Equinoxe Shoulder System, Catalog Numbers: a) 314-23-02, b) 314-23-03, c) 314-23-13, d) 314-23-14, e) 314-23-15, f)...
Medical Devices·0 affected·Nov 21, 2023
High RiskFDA
Exactech, Inc.
Exactech Equinoxe Reverse Shoulder System, Catalog Numbers: a) 320-36-00, b) 320-36-03, c) 320-36-04, d) 320-36-10, e) 320-36-...
Medical Devices·0 affected·Nov 21, 2023
High RiskFDA
Exactech, Inc.
Exactech Optetrak Logic PS Knee System, Catalog Numbers: 02-012-35-5009
Medical Devices·0 affected·Nov 21, 2023
High RiskFDA
Exactech, Inc.
Exactech Novation Hip System, Catalog Numbers: 134-36-45
Medical Devices·0 affected·Nov 21, 2023
High RiskFDA
Exactech, Inc.
Exactech Alteon Hip XLE Liner, Catalog Numbers: a) 01-030-40-0636, b) 01-030-40-0640, c) 01-030-42-0536
Medical Devices·0 affected·Nov 21, 2023
High RiskFDA
Exactech, Inc.
Exactech Optetrak Knee System, Catalog Numbers: a) 200-02-26, b) 200-02-29, c) 200-02-32, d) 200-02-35, e) 200-02-38, f) 200...
Medical Devices·0 affected·Nov 21, 2023
High RiskFDA
Exactech, Inc.
Exactech Truliant Knee System, Catalog Numbers: a) 02-012-35-3509, b) 02-022-35-1509, c) 02-022-35-1513, d) 02-022-35-3010, e)...
Medical Devices·0 affected·Nov 21, 2023
High RiskFDA
Exactech, Inc.
Exactech Ergo Impactor Handle, Catalog #321-09-05.
Medical Devices·784 affected·Jun 5, 2023
High RiskFDA
Exactech, Inc.
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH GXL 0 DEGREE LINER 28MM SZ E, REF 130-28-...
Medical Implants·11,143 affected·Aug 11, 2022
High RiskFDA
Exactech, Inc.
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH +5MM LAT LINER 15 DEG 36MM ID, SIZE H, RE...
Medical Implants·132 affected·Aug 11, 2022
High RiskFDA
Exactech, Inc.
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. 0 DEG ACUMATCH CONSTRAINED LINER SZ E 28MM ID, REF ...
Medical Implants·1,017 affected·Aug 11, 2022
High RiskFDA
Exactech, Inc.
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL...
Medical Implants·3,793 affected·Aug 11, 2022
High RiskFDA
Exactech, Inc.
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS, ...
Medical Implants·17,929 affected·Aug 11, 2022
High RiskFDA
Exactech, Inc.
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER, NEUTRAL, 28MM ID, GROUP 1 CUPS,...
Medical Implants·58,158 affected·Aug 11, 2022
High RiskFDA
Exactech, Inc.
OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XX...
Medical Devices·109,787 affected·Aug 30, 2021
High RiskFDA
Exactech, Inc.
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion...
Medical Devices·33,103 affected·Aug 30, 2021
High RiskFDA
Exactech, Inc.
ARTHROFOCUS Polyethylene Tibial Inserts (Product Line: 256-12-XX, 256-13-XX). NOTE: Information reflects Exactech recall expansion i...
Medical Devices·12 affected·Aug 30, 2021
High RiskFDA
Exactech, Inc.
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); ...
Medical Devices·2,217 affected·Aug 30, 2021
High RiskFDA
Exactech, Inc.
TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIA...
Medical Devices·31,201 affected·Aug 30, 2021
High RiskFDA
Exactech, Inc.
OPTETRAK Comprehensive Knee System custom devices labeled as the following: a. CUSTOM OPTETRAK ANGLED PS INSERT (Product Line: 900-06...
Medical Devices·41 affected·Aug 30, 2021
High RiskFDA
Exactech, Inc.
OPTETRAK Comprehensive Knee System, labeled as the following: a. OPTETRAK All-polyethylene CR Tibial Components, with Product Line Nu...
Medical Devices·242,397 affected·Aug 30, 2021
High RiskFDA
Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-40-XX, Novation GXL Liner, Neutr...
Medical Implants·89,050 affected·Jun 29, 2021
High RiskFDA
Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-32-XX, MCS +5GXL Liner 5/15 DEG ...
Medical Implants·89,050 affected·Jun 29, 2021
High RiskFDA
Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-40-XX, Novation GXL Liner, Lippe...
Medical Implants·89,050 affected·Jun 29, 2021
High RiskFDA
Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-28-XX, Acumatch GXL 15 Degree, +...
Medical Implants·89,050 affected·Jun 29, 2021
High RiskFDA
Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-22-XX, Novation GXL 10 deg Liner...
Medical Implants·89,050 affected·Jun 29, 2021
High RiskFDA
Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-28-XX, Acumatch GXL 15 Degree Li...
Medical Implants·89,050 affected·Jun 29, 2021