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Exactech, Inc. FDA Recalls
97 recalls on file across devices, 0 of them Class I and 94 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
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| Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311XClass IIFeb 3, 2026Impactor handle may be missing cross-pin |
| Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05Class IIFeb 3, 2026Impactor handle may be missing cross-pin |
| Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: 321-59-46 Software VClass IISep 5, 2025Due to products that have not completed design updates and p |
| Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: 321-59-42 Software VClass IISep 5, 2025Due to products that have not completed design updates and p |
| Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter Model/Catalog Number: 301-11-11 Software VeClass IISep 5, 2025Due to products that have not completed design updates and p |
| Exactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG PE 38MM HUM LINER +0/ 320-38-03,145-DEG PEClass IIAug 15, 2025Reverse Shoulder humeral liners have an articular surface po |
| Exactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 38MM HUM LINER +0), REF: 322-38-03 (145-DEGClass IIAug 15, 2025Reverse Shoulder humeral liners have an articular surface po |
| Novation XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV EHXLNTRL LNR G0 28MM Class IIDec 31, 2024Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier |
| 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 IIDec 31, 2024Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier |
| Alteon XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV EHXLNTRL LNR G0 28MM Class IIDec 31, 2024Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier |
| Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers: a) 100-22-19, SZ. L; b) 100-22-Class IIApr 26, 2024The AcuMatch L-Series 22mm Inner Diameter Bipolar Hip Liner |
| OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-32, 32MM; d) 200-02Class IIApr 18, 2024Exactech is recalling all affected UHMWPE (ultra-high molecu |
| OPTETRAK Inset Patella, Item Numbers: a) 200-05-23, 23MM; b) 200-05-26, 26MM; c) 200-05-29, 29MMClass IIApr 18, 2024Exactech is recalling all affected UHMWPE (ultra-high molecu |
| 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 IIApr 18, 2024Exactech is recalling all affected UHMWPE (ultra-high molecu |
| OPTETRAK, Advanced Patella, 3 Peg Implant, Item Numbers: a) 200-07-26, 26MM; b) 200-07-29, 29MM; c) 200-07-32, 32Class IIApr 18, 2024Exactech is recalling all affected UHMWPE (ultra-high molecu |
| Exactech Equinoxe Constrained Humeral Liner: Item Numbers: a) 320-40-10, b) 320-40-13, Shoulder ArthroplastyClass IIMar 6, 2024The packaging of these affected UHMWPE humeral liners and gl |
| Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item NuClass IIMar 6, 2024The packaging of these affected UHMWPE humeral liners and gl |
| Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Class IIMar 6, 2024The packaging of these affected UHMWPE humeral liners and gl |
| Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314Class IIMar 6, 2024The packaging of these affected UHMWPE humeral liners and gl |
| Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 3Class IIMar 6, 2024The packaging of these affected UHMWPE humeral liners and gl |
| Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with: a) 38, 41, 44, 47 head, Small, Class IIMar 6, 2024The packaging of these affected UHMWPE humeral liners and gl |
| Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, RIGHT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47Class IIMar 6, 2024The packaging of these affected UHMWPE humeral liners and gl |
| Exactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, Item number 320-46-10, b) +2.5mm, Item NumberClass IIMar 6, 2024The packaging of these affected UHMWPE humeral liners and gl |
| Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder ArthroplastyClass IIMar 6, 2024The packaging of these affected UHMWPE humeral liners and gl |
| Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-Class IIMar 6, 2024The packaging of these affected UHMWPE humeral liners and gl |
| Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, LEFT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 Class IIMar 6, 2024The packaging of these affected UHMWPE humeral liners and gl |
| Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item NumClass IIMar 6, 2024The packaging of these affected UHMWPE humeral liners and gl |
| Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item NumbeClass IIMar 6, 2024The packaging of these affected UHMWPE humeral liners and gl |
| Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 320-36-10, b) +2.5mm, Item NuClass IIMar 6, 2024The packaging of these affected UHMWPE humeral liners and gl |
| Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38Class IIMar 6, 2024The packaging of these affected UHMWPE humeral liners and gl |
| Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, LEFT, Mates with: a) 38, 41, 44, 47 head, Small, IClass IIMar 6, 2024The packaging of these affected UHMWPE humeral liners and gl |
| Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, bClass IIMar 6, 2024The packaging of these affected UHMWPE humeral liners and gl |
| Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-Class IIMar 6, 2024The packaging of these affected UHMWPE humeral liners and gl |
| Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314Class IIMar 6, 2024The packaging of these affected UHMWPE humeral liners and gl |
| Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03;Class IIMar 6, 2024The packaging of these affected UHMWPE humeral liners and gl |
| Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-Class IIMar 6, 2024The packaging of these affected UHMWPE humeral liners and gl |
| Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03;Class IIMar 6, 2024The packaging of these affected UHMWPE humeral liners and gl |
| Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, LEFT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 Class IIMar 6, 2024The packaging of these affected UHMWPE humeral liners and gl |
| Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, RIGHT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47Class IIMar 6, 2024The packaging of these affected UHMWPE humeral liners and gl |
| Exactech Optetrak Knee System, Catalog Numbers: a) 200-02-26, b) 200-02-29, c) 200-02-32, d) 200-02-35, e) 20Class IINov 21, 2023Exactech has received 3 complaints for 4 devices related to |
| Exactech Optetrak Logic Knee System, Catalog Numbers: a) 02-012-47-3011, b) 02-012-47-5009, c) 02-012-47-5011, Class IINov 21, 2023Exactech has received 3 complaints for 4 devices related to |
| Exactech Equinoxe Reverse Shoulder System, Catalog Numbers: a) 320-36-00, b) 320-36-03, c) 320-36-04, d) 320-36Class IINov 21, 2023Exactech has received 3 complaints for 4 devices related to |
| Exactech Optetrak Logic PS Knee System, Catalog Numbers: 02-012-35-5009Class IINov 21, 2023Exactech has received 3 complaints for 4 devices related to |
| Exactech Truliant Knee System, Catalog Numbers: a) 02-012-35-3509, b) 02-022-35-1509, c) 02-022-35-1513, d) 02-Class IINov 21, 2023Exactech has received 3 complaints for 4 devices related to |
| Exactech Truliant, Activit-E Knee Insert, Catalog Numbers: a) 02-023-02-0029, b) 02-023-02-0032, c) 02-023-02-003Class IINov 21, 2023Exactech has received 3 complaints for 4 devices related to |
| Exactech Vantage Ankle System, Catalog Numbers: a) 350-21-04, b) 350-22-03Class IINov 21, 2023Exactech has received 3 complaints for 4 devices related to |
| AcuMatch Hip System, Catalog Number 142-32-27Class IINov 21, 2023Exactech has received 3 complaints for 4 devices related to |
| Exactech Alteon Hip XLE Liner, Catalog Numbers: a) 01-030-40-0636, b) 01-030-40-0640, c) 01-030-42-0536Class IINov 21, 2023Exactech has received 3 complaints for 4 devices related to |
| Exactech Equinoxe Shoulder System, Catalog Numbers: a) 314-23-02, b) 314-23-03, c) 314-23-13, d) 314-23-14, eClass IINov 21, 2023Exactech has received 3 complaints for 4 devices related to |
| Exactech Vantage Mobile Bearing Tibial Inserts, Catalog Numbers: a) 350-41-23, b) 350-42-03Class IINov 21, 2023Exactech has received 3 complaints for 4 devices related to |
| Exactech Novation Hip System, Catalog Numbers: 134-36-45Class IINov 21, 2023Exactech has received 3 complaints for 4 devices related to |
| Exactech Shoulder GPS Impactor Handle, Catalog #531-07-05.Class IIJun 5, 2023The ball and spring housed within the locking mechanism of t |
| Exactech Ergo Impactor Handle, Catalog #321-09-05.Class IIJun 5, 2023The ball and spring housed within the locking mechanism of t |
| GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH GXL 0 DEGREE LINER 28MM Class IIAug 11, 2022Specific GXL acetabular polyethylene liners, packaged in non |
| GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM Class IIAug 11, 2022Specific GXL acetabular polyethylene liners, packaged in non |
| GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 13Class IIAug 11, 2022Specific GXL acetabular polyethylene liners, packaged in non |
| GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH +5MM LAT LINER 15 DEG 36Class IIAug 11, 2022Specific GXL acetabular polyethylene liners, packaged in non |
| GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH 15 DEGREE LINER 22MM SZ Class IIAug 11, 2022Specific GXL acetabular polyethylene liners, packaged in non |
| GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER NEUTRAL, 32MM Class IIAug 11, 2022Specific GXL acetabular polyethylene liners, packaged in non |
| GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH 0 DEGREE LINER 28MM 46MM,Class IIAug 11, 2022Specific GXL acetabular polyethylene liners, packaged in non |
| GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER, NEUTRAL, 28MM Class IIAug 11, 2022Specific GXL acetabular polyethylene liners, packaged in non |
| GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ALL POLYETHYLENE ACETABULAR CUP, Class IIAug 11, 2022Specific GXL acetabular polyethylene liners, packaged in non |
| GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. 0 DEG ACUMATCH CONSTRAINED LINER SClass IIAug 11, 2022Specific GXL acetabular polyethylene liners, packaged in non |
| OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects ExactechClass IIAug 30, 2021Inserts were packaged in vacuum bags that lacked an addition |
| OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). Class IIAug 30, 2021Inserts were packaged in vacuum bags that lacked an addition |
| TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial InsertClass IIAug 30, 2021Inserts were packaged in vacuum bags that lacked an addition |
| Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX,Class IIAug 30, 2021Inserts were packaged in vacuum bags that lacked an addition |
| OPTETRAK Comprehensive Knee System custom devices labeled as the following: a. CUSTOM OPTETRAK ANGLED PS INSERT (ProClass IIAug 30, 2021Inserts were packaged in vacuum bags that lacked an addition |
| OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Class IIAug 30, 2021Inserts were packaged in vacuum bags that lacked an addition |
| OPTETRAK Comprehensive Knee System, labeled as the following: a. OPTETRAK All-polyethylene CR Tibial Components, witClass IIAug 30, 2021Inserts were packaged in vacuum bags that lacked an addition |
| ARTHROFOCUS Polyethylene Tibial Inserts (Product Line: 256-12-XX, 256-13-XX). NOTE: Information reflects Exactech rClass IIAug 30, 2021Inserts were packaged in vacuum bags that lacked an addition |
| OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, Class IIAug 30, 2021Inserts were packaged in vacuum bags that lacked an addition |
| Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-28-XX, AcumatchClass IIJun 29, 2021Risk of edge-loading and premature prosthesis wear is possib |
| Exactech BIOLOX delta Femoral Head, 36m O.D., REF 170-36-00. Hip prosthesis component.Class IIJun 29, 2021Biolox Delta Femoral Head was packaged and labeled as 170-36 |
| Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-28-XX, AcumatchClass IIJun 29, 2021Risk of edge-loading and premature prosthesis wear is possib |
| Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-22-XX, NovationClass IIJun 29, 2021Risk of edge-loading and premature prosthesis wear is possib |
| Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-32-XX, MCS +5GXClass IIJun 29, 2021Risk of edge-loading and premature prosthesis wear is possib |
| Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-28-XX, AcumatchClass IIJun 29, 2021Risk of edge-loading and premature prosthesis wear is possib |
| Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-28-XX, MCS +5GXClass IIJun 29, 2021Risk of edge-loading and premature prosthesis wear is possib |
| Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-36-XX, NovationClass IIJun 29, 2021Risk of edge-loading and premature prosthesis wear is possib |
| Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-22-XX, NovationClass IIJun 29, 2021Risk of edge-loading and premature prosthesis wear is possib |
| Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-40-XX, NovationClass IIJun 29, 2021Risk of edge-loading and premature prosthesis wear is possib |
| Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 134-28-XX, AcumatchClass IIJun 29, 2021Risk of edge-loading and premature prosthesis wear is possib |
| Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-36-XX, AcumatchClass IIJun 29, 2021Risk of edge-loading and premature prosthesis wear is possib |
| Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-28-XX, NovationClass IIJun 29, 2021Risk of edge-loading and premature prosthesis wear is possib |
| Exactech BIOLOX delta Femoral Head, 36m O.D. + 3.5mm, REF 170-36-03. Hip prosthesis component.Class IIJun 29, 2021Biolox Delta Femoral Head was packaged and labeled as 170-36 |
| Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-32-XX, NovationClass IIJun 29, 2021Risk of edge-loading and premature prosthesis wear is possib |
| Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-22-XX, NovationClass IIJun 29, 2021Risk of edge-loading and premature prosthesis wear is possib |
| Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-36-XX, AcumatchClass IIJun 29, 2021Risk of edge-loading and premature prosthesis wear is possib |
| Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-40-XX, NovationClass IIJun 29, 2021Risk of edge-loading and premature prosthesis wear is possib |
| Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-32-XX, AcumatchClass IIJun 29, 2021Risk of edge-loading and premature prosthesis wear is possib |
| Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-36-XX, MCS +5GXClass IIJun 29, 2021Risk of edge-loading and premature prosthesis wear is possib |
| Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-32-XX, AcumatchClass IIJun 29, 2021Risk of edge-loading and premature prosthesis wear is possib |
| Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-40-XX, NovationClass IIJun 29, 2021Risk of edge-loading and premature prosthesis wear is possib |
| Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-32-XX, NovationClass IIJun 29, 2021Risk of edge-loading and premature prosthesis wear is possib |
| Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-22-XX, NovationClass IIJun 29, 2021Risk of edge-loading and premature prosthesis wear is possib |
| Humeral Augmented Tray (HAT) trials that are components of KIT-321HAT. Each tray contains 1 of each of the following cClass IIMay 11, 2021The HAT trial contains a retaining ring that has shown the p |