| 2026-02-03 |
Class II
|
Ongoing |
Z-1510-2026 |
Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311X |
— |
Impactor handle may be missing cross-pin |
| 2026-02-03 |
Class II
|
Ongoing |
Z-1509-2026 |
Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05 |
— |
Impactor handle may be missing cross-pin |
| 2025-09-05 |
Class II
|
Ongoing |
Z-0537-2026 |
Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter Model/Catalog Number: 301-11-11 Software Ve… |
— |
Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance c… |
| 2025-09-05 |
Class II
|
Ongoing |
Z-0536-2026 |
Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: 321-59-46 Software V… |
— |
Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance c… |
| 2025-09-05 |
Class II
|
Ongoing |
Z-0535-2026 |
Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: 321-59-42 Software V… |
— |
Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance c… |
| 2025-08-15 |
Class II
|
Ongoing |
Z-2562-2025 |
Exactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 38MM HUM LINER +0), REF: 322-38-03 (145-DEG… |
— |
Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling. |
| 2025-08-15 |
Class II
|
Ongoing |
Z-2561-2025 |
Exactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG PE 38MM HUM LINER +0/ 320-38-03,145-DEG PE… |
— |
Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling. |
| 2024-12-31 |
Class II
|
Ongoing |
Z-1167-2025 |
Alteon XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV EHXLNTRL LNR G0 28MM … |
— |
Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer. |
| 2024-12-31 |
Class II
|
Ongoing |
Z-1166-2025 |
Novation XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV EHXLNTRL LNR G0 28MM … |
— |
Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer. |
| 2024-12-31 |
Class II
|
Ongoing |
Z-1165-2025 |
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-… |
— |
Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer. |
| 2024-04-26 |
Class II
|
Ongoing |
Z-2236-2024 |
Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers: a) 100-22-19, SZ. L; b) 100-22-… |
— |
The AcuMatch L-Series 22mm Inner Diameter Bipolar Hip Liner lots were packaged without the specified ethylene vinyl alcohol (EVOH) layer. Between 2004 and Augus… |
| 2024-04-18 |
Class II
|
Ongoing |
Z-2158-2024 |
OPTETRAK, Advanced Patella, 3 Peg Implant, Item Numbers: a) 200-07-26, 26MM; b) 200-07-29, 29MM; c) 200-07-32, 32… |
— |
Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags. |
| 2024-04-18 |
Class II
|
Ongoing |
Z-2157-2024 |
OPTETRAK Inset Patella, Item Numbers: a) 200-05-23, 23MM; b) 200-05-26, 26MM; c) 200-05-29, 29MM |
— |
Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags. |
| 2024-04-18 |
Class II
|
Ongoing |
Z-2156-2024 |
OPTETRAK One Peg Patella,, Item Numbers: a) 200-03-26, 26MM; b) 200-03-29, 29MM; c) 200-03-32, 32MM; d) 200-03-… |
— |
Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags. |
| 2024-04-18 |
Class II
|
Ongoing |
Z-2155-2024 |
OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-32, 32MM; d) 200-02… |
— |
Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags. |
| 2024-03-06 |
Class II
|
Ongoing |
Z-1425-2024 |
Exactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, Item number 320-46-10, b) +2.5mm, Item Number… |
— |
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were pack… |
| 2024-03-06 |
Class II
|
Ongoing |
Z-1424-2024 |
Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03;… |
— |
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were pack… |
| 2024-03-06 |
Class II
|
Ongoing |
Z-1423-2024 |
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Numbe… |
— |
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were pack… |
| 2024-03-06 |
Class II
|
Ongoing |
Z-1422-2024 |
Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03;… |
— |
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were pack… |
| 2024-03-06 |
Class II
|
Ongoing |
Z-1421-2024 |
Exactech Equinoxe Constrained Humeral Liner: Item Numbers: a) 320-40-10, b) 320-40-13, Shoulder Arthroplasty |
— |
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were pack… |
| 2024-03-06 |
Class II
|
Ongoing |
Z-1420-2024 |
Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty |
— |
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were pack… |
| 2024-03-06 |
Class II
|
Ongoing |
Z-1419-2024 |
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item … |
— |
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were pack… |
| 2024-03-06 |
Class II
|
Ongoing |
Z-1418-2024 |
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38… |
— |
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were pack… |
| 2024-03-06 |
Class II
|
Ongoing |
Z-1417-2024 |
Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 320-36-10, b) +2.5mm, Item Nu… |
— |
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were pack… |
| 2024-03-06 |
Class II
|
Ongoing |
Z-1416-2024 |
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-… |
— |
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were pack… |
| 2024-03-06 |
Class II
|
Ongoing |
Z-1415-2024 |
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Nu… |
— |
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were pack… |
| 2024-03-06 |
Class II
|
Ongoing |
Z-1414-2024 |
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Num… |
— |
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were pack… |
| 2024-03-06 |
Class II
|
Ongoing |
Z-1413-2024 |
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-… |
— |
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were pack… |
| 2024-03-06 |
Class II
|
Ongoing |
Z-1412-2024 |
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-… |
— |
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were pack… |
| 2024-03-06 |
Class II
|
Ongoing |
Z-1411-2024 |
Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, RIGHT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47… |
— |
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were pack… |
| 2024-03-06 |
Class II
|
Ongoing |
Z-1410-2024 |
Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, LEFT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 … |
— |
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were pack… |
| 2024-03-06 |
Class II
|
Ongoing |
Z-1409-2024 |
Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, RIGHT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47… |
— |
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were pack… |
| 2024-03-06 |
Class II
|
Ongoing |
Z-1408-2024 |
Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, LEFT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 … |
— |
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were pack… |
| 2024-03-06 |
Class II
|
Ongoing |
Z-1407-2024 |
Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with: a) 38, 41, 44, 47 head, Small, … |
— |
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were pack… |
| 2024-03-06 |
Class II
|
Ongoing |
Z-1406-2024 |
Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, LEFT, Mates with: a) 38, 41, 44, 47 head, Small, I… |
— |
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were pack… |
| 2024-03-06 |
Class II
|
Ongoing |
Z-1405-2024 |
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b… |
— |
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were pack… |
| 2024-03-06 |
Class II
|
Ongoing |
Z-1404-2024 |
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314… |
— |
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were pack… |
| 2024-03-06 |
Class II
|
Ongoing |
Z-1403-2024 |
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314… |
— |
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were pack… |
| 2024-03-06 |
Class II
|
Ongoing |
Z-1402-2024 |
Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 3… |
— |
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were pack… |
| 2023-11-21 |
Class II
|
Ongoing |
Z-0588-2024 |
Exactech Vantage Mobile Bearing Tibial Inserts, Catalog Numbers: a) 350-41-23, b) 350-42-03 |
— |
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. |
| 2023-11-21 |
Class II
|
Ongoing |
Z-0587-2024 |
Exactech Vantage Ankle System, Catalog Numbers: a) 350-21-04, b) 350-22-03 |
— |
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. |
| 2023-11-21 |
Class II
|
Ongoing |
Z-0586-2024 |
Exactech Truliant, Activit-E Knee Insert, Catalog Numbers: a) 02-023-02-0029, b) 02-023-02-0032, c) 02-023-02-003… |
— |
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. |
| 2023-11-21 |
Class II
|
Ongoing |
Z-0585-2024 |
Exactech Truliant Knee System, Catalog Numbers: a) 02-012-35-3509, b) 02-022-35-1509, c) 02-022-35-1513, d) 02-… |
— |
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. |
| 2023-11-21 |
Class II
|
Ongoing |
Z-0584-2024 |
Exactech Optetrak Logic PS Knee System, Catalog Numbers: 02-012-35-5009 |
— |
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. |
| 2023-11-21 |
Class II
|
Ongoing |
Z-0583-2024 |
Exactech Optetrak Logic Knee System, Catalog Numbers: a) 02-012-47-3011, b) 02-012-47-5009, c) 02-012-47-5011, … |
— |
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. |
| 2023-11-21 |
Class II
|
Ongoing |
Z-0582-2024 |
Exactech Optetrak Knee System, Catalog Numbers: a) 200-02-26, b) 200-02-29, c) 200-02-32, d) 200-02-35, e) 20… |
— |
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. |
| 2023-11-21 |
Class II
|
Ongoing |
Z-0581-2024 |
Exactech Novation Hip System, Catalog Numbers: 134-36-45 |
— |
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. |
| 2023-11-21 |
Class II
|
Ongoing |
Z-0580-2024 |
Exactech Equinoxe Shoulder System, Catalog Numbers: a) 314-23-02, b) 314-23-03, c) 314-23-13, d) 314-23-14, e… |
— |
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. |
| 2023-11-21 |
Class II
|
Ongoing |
Z-0579-2024 |
Exactech Equinoxe Reverse Shoulder System, Catalog Numbers: a) 320-36-00, b) 320-36-03, c) 320-36-04, d) 320-36… |
— |
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. |
| 2023-11-21 |
Class II
|
Ongoing |
Z-0578-2024 |
Exactech Alteon Hip XLE Liner, Catalog Numbers: a) 01-030-40-0636, b) 01-030-40-0640, c) 01-030-42-0536 |
— |
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. |
| 2023-11-21 |
Class II
|
Ongoing |
Z-0577-2024 |
AcuMatch Hip System, Catalog Number 142-32-27 |
— |
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. |
| 2023-06-05 |
Class II
|
Ongoing |
Z-2051-2023 |
Exactech Ergo Impactor Handle, Catalog #321-09-05. |
— |
The ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction. |
| 2023-06-05 |
Class II
|
Ongoing |
Z-2050-2023 |
Exactech Shoulder GPS Impactor Handle, Catalog #531-07-05. |
— |
The ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction. |
| 2022-08-11 |
Class II
|
Ongoing |
Z-1734-2022 |
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH 0 DEGREE LINER 28MM 46MM,… |
— |
Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear. |
| 2022-08-11 |
Class II
|
Ongoing |
Z-1733-2022 |
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ALL POLYETHYLENE ACETABULAR CUP, … |
— |
Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear. |
| 2022-08-11 |
Class II
|
Ongoing |
Z-1732-2022 |
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER NEUTRAL, 32MM … |
— |
Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear. |
| 2022-08-11 |
Class II
|
Ongoing |
Z-1731-2022 |
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 13… |
— |
Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear. |
| 2022-08-11 |
Class II
|
Ongoing |
Z-1730-2022 |
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM … |
— |
Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear. |
| 2022-08-11 |
Class II
|
Ongoing |
Z-1729-2022 |
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER, NEUTRAL, 28MM … |
— |
Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear. |
| 2022-08-11 |
Class II
|
Ongoing |
Z-1728-2022 |
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH GXL 0 DEGREE LINER 28MM … |
— |
Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear. |
| 2022-08-11 |
Class II
|
Ongoing |
Z-1727-2022 |
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH +5MM LAT LINER 15 DEG 36… |
— |
Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear. |
| 2022-08-11 |
Class II
|
Ongoing |
Z-1726-2022 |
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH 15 DEGREE LINER 22MM SZ … |
— |
Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear. |
| 2022-08-11 |
Class II
|
Ongoing |
Z-1725-2022 |
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. 0 DEG ACUMATCH CONSTRAINED LINER S… |
— |
Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear. |
| 2021-08-30 |
Class II
|
Ongoing |
Z-0027-2022 |
ARTHROFOCUS Polyethylene Tibial Inserts (Product Line: 256-12-XX, 256-13-XX). NOTE: Information reflects Exactech r… |
— |
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. |
| 2021-08-30 |
Class II
|
Ongoing |
Z-0026-2022 |
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). … |
— |
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. |
| 2021-08-30 |
Class II
|
Ongoing |
Z-0025-2022 |
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech… |
— |
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. |
| 2021-08-30 |
Class II
|
Ongoing |
Z-0024-2022 |
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX,… |
— |
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. |
| 2021-08-30 |
Class II
|
Ongoing |
Z-0023-2022 |
TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Insert… |
— |
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. |
| 2021-08-30 |
Class II
|
Ongoing |
Z-0022-2022 |
OPTETRAK Comprehensive Knee System custom devices labeled as the following: a. CUSTOM OPTETRAK ANGLED PS INSERT (Pro… |
— |
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. |
| 2021-08-30 |
Class II
|
Ongoing |
Z-0021-2022 |
OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product … |
— |
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. |
| 2021-08-30 |
Class II
|
Ongoing |
Z-0020-2022 |
OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, … |
— |
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. |
| 2021-08-30 |
Class II
|
Ongoing |
Z-0019-2022 |
OPTETRAK Comprehensive Knee System, labeled as the following: a. OPTETRAK All-polyethylene CR Tibial Components, wit… |
— |
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. |
| 2021-06-29 |
Class II
|
Completed |
Z-2251-2021 |
Exactech BIOLOX delta Femoral Head, 36m O.D. + 3.5mm, REF 170-36-03. Hip prosthesis component. |
— |
Biolox Delta Femoral Head was packaged and labeled as 170-36-00 (36mm +0), but the device was marked as 170-36-03 (36mm +3.5). |
| 2021-06-29 |
Class II
|
Completed |
Z-2250-2021 |
Exactech BIOLOX delta Femoral Head, 36m O.D., REF 170-36-00. Hip prosthesis component. |
— |
Biolox Delta Femoral Head was packaged and labeled as 170-36-00 (36mm +0), but the device was marked as 170-36-03 (36mm +3.5). |
| 2021-06-29 |
Class II
|
Ongoing |
Z-2133-2021 |
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-32-XX, Acumatch… |
— |
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positio… |
| 2021-06-29 |
Class II
|
Ongoing |
Z-2132-2021 |
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-32-XX, Novation… |
— |
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positio… |
| 2021-06-29 |
Class II
|
Ongoing |
Z-2131-2021 |
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-28-XX, Acumatch… |
— |
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positio… |
| 2021-06-29 |
Class II
|
Ongoing |
Z-2130-2021 |
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-22-XX, Novation… |
— |
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positio… |
| 2021-06-29 |
Class II
|
Ongoing |
Z-2129-2021 |
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-40-XX, Novation… |
— |
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positio… |
| 2021-06-29 |
Class II
|
Ongoing |
Z-2128-2021 |
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-36-XX, Novation… |
— |
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positio… |
| 2021-06-29 |
Class II
|
Ongoing |
Z-2127-2021 |
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-32-XX, Novation… |
— |
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positio… |
| 2021-06-29 |
Class II
|
Ongoing |
Z-2126-2021 |
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-28-XX, Novation… |
— |
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positio… |
| 2021-06-29 |
Class II
|
Ongoing |
Z-2125-2021 |
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-22-XX, Novation… |
— |
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positio… |
| 2021-06-29 |
Class II
|
Ongoing |
Z-2124-2021 |
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 134-28-XX, Acumatch… |
— |
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positio… |
| 2021-06-29 |
Class II
|
Ongoing |
Z-2123-2021 |
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-40-XX, Novation… |
— |
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positio… |
| 2021-06-29 |
Class II
|
Ongoing |
Z-2122-2021 |
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-36-XX, Acumatch… |
— |
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positio… |
| 2021-06-29 |
Class II
|
Ongoing |
Z-2121-2021 |
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-28-XX, Acumatch… |
— |
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positio… |
| 2021-06-29 |
Class II
|
Ongoing |
Z-2120-2021 |
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-22-XX, Novation… |
— |
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positio… |
| 2021-06-29 |
Class II
|
Ongoing |
Z-2119-2021 |
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-40-XX, Novation… |
— |
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positio… |
| 2021-06-29 |
Class II
|
Ongoing |
Z-2118-2021 |
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-36-XX, Acumatch… |
— |
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positio… |
| 2021-06-29 |
Class II
|
Ongoing |
Z-2117-2021 |
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-32-XX, Acumatch… |
— |
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positio… |
| 2021-06-29 |
Class II
|
Ongoing |
Z-2116-2021 |
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-28-XX, Acumatch… |
— |
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positio… |
| 2021-06-29 |
Class II
|
Ongoing |
Z-2115-2021 |
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-22-XX, Novation… |
— |
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positio… |
| 2021-06-29 |
Class II
|
Ongoing |
Z-2114-2021 |
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-36-XX, MCS +5GX… |
— |
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positio… |
| 2021-06-29 |
Class II
|
Ongoing |
Z-2113-2021 |
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-32-XX, MCS +5GX… |
— |
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positio… |
| 2021-06-29 |
Class II
|
Ongoing |
Z-2112-2021 |
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-28-XX, MCS +5GX… |
— |
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positio… |
| 2021-05-11 |
Class II
|
Completed |
Z-1977-2021 |
Humeral Augmented Tray (HAT) trials that are components of KIT-321HAT. Each tray contains 1 of each of the following c… |
— |
The HAT trial contains a retaining ring that has shown the potential to disengage during use. |
| 2020-11-09 |
Class II
|
Ongoing |
Z-0884-2021 |
Equinoxe Humeral Stem, Primary, Press Fit, 11mm |
— |
Potential for incorrect Instructions For Use (IFU) included with an Equinoxe Humeral Stem, Primary, Press Fit, 11mm package. |
| 2020-10-06 |
Class II
|
Terminated |
Z-0460-2021 |
Catalog 314-13-33, Equinoxe Cage Glenoid, Posterior Augment, Right, Medium |
— |
The product may be mislabeled. |
| 2020-10-06 |
Class II
|
Terminated |
Z-0459-2021 |
Catalog 314-13-23, Equinoxe Cage Glenoid, Posterior Augment, Left, Medium |
— |
The product may be mislabeled. |
| 2020-09-25 |
Class II
|
Terminated |
Z-0308-2021 |
Equinoxe Platform Fracture Stem, 6.5mm, Right - Product Usage: The Equinoxe Platform Fracture Stem is indicated for ceme… |
— |
The device may be incorrectly laser marked as a right stem, when it should have been laser marked as a left stem. |
| 2020-09-25 |
Class II
|
Terminated |
Z-0307-2021 |
Equinoxe Platform Fracture Stem, 6.5mm, Left - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemen… |
— |
The device may be incorrectly laser marked as a right stem, when it should have been laser marked as a left stem. |
| 2020-08-24 |
Class II
|
Terminated |
Z-3020-2020 |
Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm. |
— |
Exactech is recalling the Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit, because it may contain a incorrect length screw. |
| 2020-08-24 |
Class II
|
Terminated |
Z-3019-2020 |
Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 18 mm. |
— |
Exactech is recalling the Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit, because it may contain a incorrect length screw. |
| 2020-08-10 |
Class II
|
Ongoing |
Z-2926-2020 |
The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm. |
— |
The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm, were found to have a labeling error. Exactech is recalling the Vantage Total Ankle Ti… |
| 2020-01-27 |
Class II
|
Ongoing |
Z-1364-2020 |
Truliant Splined Stem Extension, 18mm x 120mm - Product Usage: The devices are used in a cemented total knee prosthesis … |
— |
These Truliant Splined Stem Extension, 18mm x 120mm were found to have a labeling error. The upper right corner of the label incorrectly identifies the implant … |