FDA recall record · openFDA
Exactech, Inc.
53 FDA recalls on record (2023–2026) — 53 device. 53 still ongoing.
0
Class I (most serious)
53
Class II
0
Class III
53
ongoing
How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.
Most common reasons
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established 24
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. 12
Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in 4
Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer. 3
Due to products that have not completed design updates and performance testing being released/distributed. Products may 3
Recalls
Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05 Class II 2026-02-03 Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311X Class II 2026-02-03 Exactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 38MM HUM LINER +0), REF: 322-38-03 (145-DEG Class II 2025-08-15 Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: 321-59-46 Software V Class II 2025-09-05 Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter Model/Catalog Number: 301-11-11 Software Ve Class II 2025-09-05 Exactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG PE 38MM HUM LINER +0/ 320-38-03,145-DEG PE Class II 2025-08-15 Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: 321-59-42 Software V Class II 2025-09-05 Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, RIGHT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 Class II 2024-03-06 Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with: a) 38, 41, 44, 47 head, Small, Class II 2024-03-06 Exactech Equinoxe Constrained Humeral Liner: Item Numbers: a) 320-40-10, b) 320-40-13, Shoulder Arthroplasty Class II 2024-03-06 Exactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, Item number 320-46-10, b) +2.5mm, Item Number Class II 2024-03-06 Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty Class II 2024-03-06 Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13- Class II 2024-03-06 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- Class II 2024-12-31 Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Nu Class II 2024-03-06 Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b Class II 2024-03-06 OPTETRAK Inset Patella, Item Numbers: a) 200-05-23, 23MM; b) 200-05-26, 26MM; c) 200-05-29, 29MM Class II 2024-04-18 OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-32, 32MM; d) 200-02 Class II 2024-04-18 Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314 Class II 2024-03-06 Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Class II 2024-03-06 Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314 Class II 2024-03-06 Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36- Class II 2024-03-06 Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, LEFT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 Class II 2024-03-06 Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Num Class II 2024-03-06 Novation XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV EHXLNTRL LNR G0 28MM Class II 2024-12-31 Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 3 Class II 2024-03-06 Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Numbe Class II 2024-03-06 Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 320-36-10, b) +2.5mm, Item Nu Class II 2024-03-06 Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers: a) 100-22-19, SZ. L; b) 100-22- Class II 2024-04-26 Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Class II 2024-03-06 Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38 Class II 2024-03-06 Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, LEFT, Mates with: a) 38, 41, 44, 47 head, Small, I Class II 2024-03-06 Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13- Class II 2024-03-06 Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Class II 2024-03-06 Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, LEFT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 Class II 2024-03-06 Alteon XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV EHXLNTRL LNR G0 28MM Class II 2024-12-31 OPTETRAK, Advanced Patella, 3 Peg Implant, Item Numbers: a) 200-07-26, 26MM; b) 200-07-29, 29MM; c) 200-07-32, 32 Class II 2024-04-18 Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, RIGHT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 Class II 2024-03-06 OPTETRAK One Peg Patella,, Item Numbers: a) 200-03-26, 26MM; b) 200-03-29, 29MM; c) 200-03-32, 32MM; d) 200-03- Class II 2024-04-18 AcuMatch Hip System, Catalog Number 142-32-27 Class II 2023-11-21 Exactech Equinoxe Shoulder System, Catalog Numbers: a) 314-23-02, b) 314-23-03, c) 314-23-13, d) 314-23-14, e Class II 2023-11-21 Exactech Ergo Impactor Handle, Catalog #321-09-05. Class II 2023-06-05 Exactech Equinoxe Reverse Shoulder System, Catalog Numbers: a) 320-36-00, b) 320-36-03, c) 320-36-04, d) 320-36 Class II 2023-11-21 Exactech Optetrak Logic PS Knee System, Catalog Numbers: 02-012-35-5009 Class II 2023-11-21 Exactech Novation Hip System, Catalog Numbers: 134-36-45 Class II 2023-11-21 Exactech Alteon Hip XLE Liner, Catalog Numbers: a) 01-030-40-0636, b) 01-030-40-0640, c) 01-030-42-0536 Class II 2023-11-21 Exactech Optetrak Knee System, Catalog Numbers: a) 200-02-26, b) 200-02-29, c) 200-02-32, d) 200-02-35, e) 20 Class II 2023-11-21 Exactech Truliant Knee System, Catalog Numbers: a) 02-012-35-3509, b) 02-022-35-1509, c) 02-022-35-1513, d) 02- Class II 2023-11-21 Exactech Truliant, Activit-E Knee Insert, Catalog Numbers: a) 02-023-02-0029, b) 02-023-02-0032, c) 02-023-02-003 Class II 2023-11-21 Exactech Vantage Mobile Bearing Tibial Inserts, Catalog Numbers: a) 350-41-23, b) 350-42-03 Class II 2023-11-21 Exactech Optetrak Logic Knee System, Catalog Numbers: a) 02-012-47-3011, b) 02-012-47-5009, c) 02-012-47-5011, Class II 2023-11-21 Exactech Vantage Ankle System, Catalog Numbers: a) 350-21-04, b) 350-22-03 Class II 2023-11-21 Exactech Shoulder GPS Impactor Handle, Catalog #531-07-05. Class II 2023-06-05
RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.