Exactech, Inc.
Gainesville, FL
This page shows every FDA and USDA recall linked to Exactech, Inc.. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
219
Total Recalls
2003
First Recall
2025
Most Recent
Brand Name: Equinoxe Ergo
Product Name: Ergo Augments Pilot Tip Converter
Model/Catalog Number: 301-11-11
Soft...
Nov 17, 2025
· Device
Open, Classified
Brand Name: Equinoxe Ergo
Product Name: Adjustable Angle rTSA Reamer, 42mm
Model/Catalog Number: 321-59-42
Sof...
Nov 17, 2025
· Device
Open, Classified
Brand Name: Equinoxe Ergo
Product Name: Adjustable Angle rTSA Reamer, 46mm
Model/Catalog Number: 321-59-46
Sof...
Nov 17, 2025
· Device
Open, Classified
Exactech Equinoxe, Reverse Shoulder Humeral Liners,
REF: 320-38-00,145-DEG PE 38MM HUM LINER +0/
320-38-03,14...
Sep 12, 2025
· Device
Open, Classified
Exactech Equinoxe, Reverse Shoulder Humeral Liners,
322-38-00 (145-DEG PE 38MM HUM LINER +0),
REF: 322-38-03...
Sep 12, 2025
· Device
Open, Classified
Novation XLE
Item Number / Product Description:
140-22-70 NV EHXL NTL LNR G00 22MM
140-28-50 NV EHXLNTRL LNR G...
Feb 12, 2025
· Device
Open, Classified
Alteon XLE
Item Number / Product Description:
140-22-70 NV EHXL NTL LNR G00 22MM
140-28-50 NV EHXLNTRL LNR G0...
Feb 12, 2025
· Device
Open, Classified
AcuMatch XLE
Item Number / Product Description:
140-28-27 AM EHXL 0 LNR G 28MM
140-32-27 AM EHXL 0 LNR G 32MM...
Feb 12, 2025
· Device
Open, Classified
Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers:
a) 100-22-19, SZ. L;
b)...
Jun 28, 2024
· Device
Open, Classified
OPTETRAK Three Peg Patella, Item Numbers:
a) 200-02-26, 26MM;
b) 200-02-29, 29MM;
c) 200-02-32, 32MM;
d)...
Jun 18, 2024
· Device
Open, Classified
OPTETRAK, Advanced Patella, 3 Peg Implant, Item Numbers:
a) 200-07-26, 26MM;
b) 200-07-29, 29MM;
c) 200-07...
Jun 18, 2024
· Device
Open, Classified
OPTETRAK One Peg Patella,, Item Numbers:
a) 200-03-26, 26MM;
b) 200-03-29, 29MM;
c) 200-03-32, 32MM;
d) 2...
Jun 18, 2024
· Device
Open, Classified
OPTETRAK Inset Patella, Item Numbers:
a) 200-05-23, 23MM;
b) 200-05-26, 26MM;
c) 200-05-29, 29MM
Jun 18, 2024
· Device
Open, Classified
Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner:
a) +0mm, Item Number 320-36-10,
b) +2.5mm,...
Mar 29, 2024
· Device
Open, Classified
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item...
Mar 29, 2024
· Device
Open, Classified
Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Ite...
Mar 29, 2024
· Device
Open, Classified
Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty
Mar 29, 2024
· Device
Open, Classified
Exactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, Item number 320-46-10, b) +2.5mm, I...
Mar 29, 2024
· Device
Open, Classified
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner:
a) +0mm, Item Number 320-38-00,
b) +2.5mm, Item Numbe...
Mar 29, 2024
· Device
Open, Classified
Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number...
Mar 29, 2024
· Device
Open, Classified
Exactech Equinoxe Constrained Humeral Liner: Item Numbers: a) 320-40-10, b) 320-40-13, Shoulder Arthroplasty
Mar 29, 2024
· Device
Open, Classified
Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, LEFT, Mates with:
a) 38, 41, 44, 47 head,...
Mar 29, 2024
· Device
Open, Classified
Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, RIGHT, FOR CEMENTED USE ONLY, Mates with:
a) 38, 4...
Mar 29, 2024
· Device
Open, Classified
Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with:
a) 38, 41, 44, 47 head...
Mar 29, 2024
· Device
Open, Classified
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm,...
Mar 29, 2024
· Device
Open, Classified
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with:
a) 47, 50, 53 head, Medium, Item Numbe...
Mar 29, 2024
· Device
Open, Classified
Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, LEFT, FOR CEMENTED USE ONLY, Mates with:
a) 38, 41...
Mar 29, 2024
· Device
Open, Classified
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner:
a) +0mm, Item Number 320-36-00,
b) +2.5mm, Item Number...
Mar 29, 2024
· Device
Open, Classified
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item...
Mar 29, 2024
· Device
Open, Classified
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with:
a) 38, 41, 44, 47 head, Small...
Mar 29, 2024
· Device
Open, Classified
Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number...
Mar 29, 2024
· Device
Open, Classified
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner:
a) +0mm, Item Number 320-38-10,
b) +2.5m...
Mar 29, 2024
· Device
Open, Classified
Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, LEFT, FOR CEMENTED USE ONLY, Mates with:
a) 38, 41...
Mar 29, 2024
· Device
Open, Classified
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with:
a) 38, 41, 44, 47 head, Small,...
Mar 29, 2024
· Device
Open, Classified
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with:
a) 38, 41, 44 head, Small, Item Numbe...
Mar 29, 2024
· Device
Open, Classified
Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, RIGHT, FOR CEMENTED USE ONLY, Mates with:
a) 38, 4...
Mar 29, 2024
· Device
Open, Classified
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes:
a) Small, Item Number 314...
Mar 29, 2024
· Device
Open, Classified
Exactech Equinoxe Shoulder System, Catalog Numbers:
a) 314-23-02,
b) 314-23-03,
c) 314-23-13,
d) 314-23-1...
Jan 18, 2024
· Device
Open, Classified
Exactech Truliant Knee System, Catalog Numbers:
a) 02-012-35-3509,
b) 02-022-35-1509,
c) 02-022-35-1513,...
Jan 18, 2024
· Device
Open, Classified
Exactech Optetrak Logic Knee System, Catalog Numbers:
a) 02-012-47-3011,
b) 02-012-47-5009,
c) 02-012-47-5...
Jan 18, 2024
· Device
Open, Classified
Exactech Optetrak Logic PS Knee System, Catalog Numbers: 02-012-35-5009
Jan 18, 2024
· Device
Open, Classified
Exactech Vantage Ankle System, Catalog Numbers:
a) 350-21-04,
b) 350-22-03
Jan 18, 2024
· Device
Open, Classified
Exactech Alteon Hip XLE Liner, Catalog Numbers:
a) 01-030-40-0636,
b) 01-030-40-0640,
c) 01-030-42-0536
Jan 18, 2024
· Device
Open, Classified
AcuMatch Hip System, Catalog Number 142-32-27
Jan 18, 2024
· Device
Open, Classified
Exactech Novation Hip System, Catalog Numbers: 134-36-45
Jan 18, 2024
· Device
Open, Classified
Exactech Vantage Mobile Bearing Tibial Inserts, Catalog Numbers:
a) 350-41-23,
b) 350-42-03
Jan 18, 2024
· Device
Open, Classified
Exactech Truliant, Activit-E Knee Insert, Catalog Numbers:
a) 02-023-02-0029,
b) 02-023-02-0032,
c) 02-023...
Jan 18, 2024
· Device
Open, Classified
Exactech Optetrak Knee System, Catalog Numbers:
a) 200-02-26,
b) 200-02-29,
c) 200-02-32,
d) 200-02-35,...
Jan 18, 2024
· Device
Open, Classified
Exactech Equinoxe Reverse Shoulder System, Catalog Numbers:
a) 320-36-00,
b) 320-36-03,
c) 320-36-04,
d)...
Jan 18, 2024
· Device
Open, Classified
Exactech Ergo Impactor Handle, Catalog #321-09-05.
Jun 30, 2023
· Device
Open, Classified