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Sign in to claim this brandExactech, Inc.
United States·US-MF-000017730
Last updated September 17, 2026
What Exactech, Inc. makes
Exactech, Inc. manufactures orthopaedic implants and surgical instruments, including tibial inserts, knee and ankle prostheses (both trial and fixed-bearing), acetabular shells, and non-bioabsorbable orthopaedic bone screws. Their reusable trial components for knee and tibia prostheses, as well as instrument trays, support preoperative planning and intraoperative procedures. Fixed-bearing total ankle prostheses and acetabular shells are designed for primary and revision joint replacements.
The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. Their products are regulated under the U.S. Food and Drug Administration’s medical device rules, with compliance required for market distribution in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Exactech, Inc. manufacture?
Exactech, Inc. specializes in orthopaedic implants and surgical instruments. Their product lineup includes tibial inserts, knee and ankle prostheses (both trial and fixed-bearing types), acetabular shells, and non-bioabsorbable orthopaedic bone screws. They also produce reusable trial components for knee and tibia prostheses, as well as instrument trays, which aid in preoperative planning and intraoperative procedures. These devices are designed for joint replacement surgeries, including primary and revision cases.
Where is Exactech, Inc. based?
Exactech, Inc. is headquartered in the United States. While the exact location isn’t specified, the company operates within the U.S. regulatory framework, which governs its medical device offerings.
Which regulatory registries list Exactech, Inc.’s devices?
Exactech, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and compliance tracking for medical devices marketed in the United States, aligning with FDA requirements for device identification and reporting.
How are Exactech, Inc.’s devices classified under FDA regulations?
Exactech, Inc.’s devices fall under FDA’s Class I and Class II categories. Class I devices generally pose minimal risk and are subject to general controls, while Class II devices require additional performance standards or special controls due to moderate risk. The classification depends on factors like the device’s intended use, potential risks, and the body part involved, ensuring appropriate regulatory oversight.
What is the purpose of Exactech’s reusable trial components and instrument trays?
Exactech’s reusable trial components, such as knee and tibia prosthesis trials, are designed for intraoperative use to assess fit, alignment, and function before final implantation. These components help surgeons plan and refine the procedure, reducing the risk of complications. Instrument trays, also reusable, contain the necessary tools for surgical procedures, ensuring efficiency and sterility during orthopaedic surgeries.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 2320, NW 66th Court, Gainesville, United States
- Website
- www.advita.com
- —
- —
- [email protected]
- Phone
- (352) 377-1140
- PRRC Contact
- Christine Thomas
- EUDAMED SRN
- US-MF-000017730
- FDA FEI Number
- 1038671
- DUNS Number
- 157565946
Catalogue (10455)
Page 35 of 210| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Alteon | 01-031-42-0228 | FDA UDI | Class I | Active |
| Equinoxe | 321-17-33 | FDA UDI | Class II | Active |
| Equinoxe | 308-15-75 | FDA UDI | Class II | Active |
| Epic | 2001-5540 | FDA UDI | Class II | Active |
| Equinoxe | 321-40-10 | FDA UDI | Class I | Active |
| Optetrak Logic | 02-011-06-0850 | FDA UDI | Class I | Active |
| Optetrak Logic | 02-010-06-0531 | FDA UDI | Class II | Active |
| Truliant | 02-029-90-6000 | FDA UDI | Class II | Active |
| Truliant CC | 02-012-65-9113 | FDA UDI | Class II | Active |
| Vantage®, Activit-E | 350-23-55 | FDA UDI | Class II | Active |
| Epic Cannulated Screw System | A | FDA UDI | Class II | Active |
| Vantage®, Activit-E | 351-24-82 | FDA UDI | Class I | Active |
| Truliant CC | 02-011-06-0920 | FDA UDI | Class II | Active |
| Truliant | 02-029-01-0091 | FDA UDI | Class I | Active |
| Alteon | 01-011-15-2295 | FDA UDI | Class I | Active |
| Alteon | 01-010-21-4195 | FDA UDI | Class II | Active |
| Equinoxe® | 322-10-10 | FDA UDI | Class II | Active |
| Vantage | 351-22-64 | FDA UDI | Class I | Active |
| Truliant | 02-521-20-2004 | FDA UDI | Class II | Unknown |
| Optetrak Logic | 02-011-06-0120 | FDA UDI | Class I | Active |
| Truliant CC | 02-010-07-5510 | FDA UDI | Class II | Active |
| Equinoxe | 310-22-44 | FDA UDI | Class II | Active |
| Truliant | 02-029-90-3000 | FDA UDI | Class I | Active |
| Optetrak Logic | 02-012-35-2019 | FDA UDI | Class II | Active |
| Optetrak Logic | 02-012-44-1009 | FDA UDI | Class II | Active |
| Equinoxe | 315-25-12 | FDA UDI | Class II | Active |
| Truliant | 02-022-47-4011 | FDA UDI | Class II | Active |
| Exactech | 100-36-05 | FDA UDI | Class II | Active |
| Aura | 107-02-01 | FDA UDI | Class II | Active |
| Truliant | 02-022-47-6013 | FDA UDI | Class II | Active |
| AcuMatch | 142-28-25 | FDA UDI | Class II | Active |
| Truliant | SPI-050027 | FDA UDI | Class II | Active |
| Optetrak Logic | 02-013-65-2000 | FDA UDI | Class I | Active |
| Equinoxe® | 324-38-00 | FDA UDI | Class II | Active |
| Alteon | 191-02-09 | FDA UDI | Class II | Active |
| Optetrak Logic | 02-012-65-3015 | FDA UDI | Class II | Active |
| Optetrak Logic | 02-013-52-5008 | FDA UDI | Class I | Unknown |
| Epic Fracture Plate System | A | FDA UDI | Class II | Active |
| Equinoxe | 315-04-24 | FDA UDI | Class I | Active |
| Equinoxe | 308-05-31 | FDA UDI | Class II | Active |
| Vantage®, Activit-E | 351-24-45 | FDA UDI | Class I | Active |
| Truliant | 02-022-47-6015 | FDA UDI | Class II | Active |
| Optetrak Logic | 02-012-65-9115 | FDA UDI | Class II | Active |
| Alteon | 188-01-03 | FDA UDI | Class II | Active |
| Optetrak Logic | 02-013-45-9320 | FDA UDI | Class I | Active |
| Truliant | 02-022-35-5014 | FDA UDI | Class II | Active |
| Exactechgps | A10005 | FDA UDI | Class II | Active |
| Exactech | 100-32-05 | FDA UDI | Class II | Active |
| Novation | 181-00-62 | FDA UDI | Class I | Active |
| Equinoxe | 310-62-41 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
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Notified Bodies
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Authorities
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FDA Recalls (100)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Exactech, Inc. has 221 recall records spanning from June 17, 2003, to February 3, 2026, with statuses including completed, open, classified, and terminated. The reasons cited involve labeling inaccuracies—such as incorrect size information, transposed device labels, and mismatched inner packaging—along with design and manufacturing issues, including missing components (e.g., cross-pins), improper markings, misalignment of fixation holes, and non-conforming threads. Some recalls address updated instructions for use to clarify surgical techniques, while others involve uncompleted design updates or missing specified coatings on implants.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Feb 3, 2026 | Z-1510-2026 | — | open, classified | Impactor handle may be missing cross-pin |
| Feb 3, 2026 | Z-1509-2026 | — | open, classified | Impactor handle may be missing cross-pin |
| Sep 5, 2025 | Z-0536-2026 | — | open, classified | Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria. |
| Sep 5, 2025 | Z-0537-2026 | — | open, classified | Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria. |
| Sep 5, 2025 | Z-0535-2026 | — | open, classified | Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria. |
| Aug 15, 2025 | Z-2561-2025 | — | open, classified | Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling. |
| Aug 15, 2025 | Z-2562-2025 | — | open, classified | Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling. |
| Dec 31, 2024 | Z-1166-2025 | — | open, classified | Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer. |
| Dec 31, 2024 | Z-1167-2025 | — | open, classified | Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer. |
| Dec 31, 2024 | Z-1165-2025 | — | open, classified | Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer. |
| Apr 26, 2024 | Z-2236-2024 | — | open, classified | The AcuMatch L-Series 22mm Inner Diameter Bipolar Hip Liner lots were packaged without the specified ethylene vinyl alcohol (EVOH) layer. Between 2004 and August 2021, our packaging process utilized two different types of packaging materials: 1) Low Density Polyethylene (LDPE), Nylon, and EVOH, or 2) LDPE and Nylon without EVOH. |
| Apr 18, 2024 | Z-2156-2024 | — | open, classified | Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags. |
| Apr 18, 2024 | Z-2158-2024 | — | open, classified | Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags. |
| Apr 18, 2024 | Z-2155-2024 | — | open, classified | Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags. |
| Apr 18, 2024 | Z-2157-2024 | — | open, classified | Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags. |
| Mar 6, 2024 | Z-1420-2024 | — | open, classified | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH). |
| Mar 6, 2024 | Z-1423-2024 | — | open, classified | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH). |
| Mar 6, 2024 | Z-1414-2024 | — | open, classified | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH). |
| Mar 6, 2024 | Z-1422-2024 | — | open, classified | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH). |
| Mar 6, 2024 | Z-1406-2024 | — | open, classified | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH). |
| Mar 6, 2024 | Z-1409-2024 | — | open, classified | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH). |
| Mar 6, 2024 | Z-1415-2024 | — | open, classified | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH). |
| Mar 6, 2024 | Z-1405-2024 | — | open, classified | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH). |
| Mar 6, 2024 | Z-1416-2024 | — | open, classified | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH). |
| Mar 6, 2024 | Z-1403-2024 | — | open, classified | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH). |
| Mar 6, 2024 | Z-1407-2024 | — | open, classified | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH). |
| Mar 6, 2024 | Z-1411-2024 | — | open, classified | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH). |
| Mar 6, 2024 | Z-1410-2024 | — | open, classified | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH). |
| Mar 6, 2024 | Z-1425-2024 | — | open, classified | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH). |
| Mar 6, 2024 | Z-1412-2024 | — | open, classified | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH). |
| Mar 6, 2024 | Z-1417-2024 | — | open, classified | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH). |
| Mar 6, 2024 | Z-1424-2024 | — | open, classified | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH). |
| Mar 6, 2024 | Z-1404-2024 | — | open, classified | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH). |
| Mar 6, 2024 | Z-1402-2024 | — | open, classified | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH). |
| Mar 6, 2024 | Z-1408-2024 | — | open, classified | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH). |
| Mar 6, 2024 | Z-1421-2024 | — | open, classified | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH). |
| Mar 6, 2024 | Z-1413-2024 | — | open, classified | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH). |
| Mar 6, 2024 | Z-1418-2024 | — | open, classified | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH). |
| Mar 6, 2024 | Z-1419-2024 | — | open, classified | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH). |
| Nov 21, 2023 | Z-0582-2024 | — | open, classified | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. |
| Nov 21, 2023 | Z-0587-2024 | — | open, classified | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. |
| Nov 21, 2023 | Z-0588-2024 | — | open, classified | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. |
| Nov 21, 2023 | Z-0586-2024 | — | open, classified | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. |
| Nov 21, 2023 | Z-0584-2024 | — | open, classified | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. |
| Nov 21, 2023 | Z-0581-2024 | — | open, classified | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. |
| Nov 21, 2023 | Z-0580-2024 | — | open, classified | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. |
| Nov 21, 2023 | Z-0583-2024 | — | open, classified | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. |
| Nov 21, 2023 | Z-0585-2024 | — | open, classified | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. |
| Nov 21, 2023 | Z-0579-2024 | — | open, classified | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. |
| Nov 21, 2023 | Z-0578-2024 | — | open, classified | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. |
| Nov 21, 2023 | Z-0577-2024 | — | open, classified | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. |
| Jun 5, 2023 | Z-2051-2023 | — | open, classified | The ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction. |
| Jun 5, 2023 | Z-2050-2023 | — | open, classified | The ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction. |
| Aug 11, 2022 | Z-1726-2022 | — | open, classified | Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear. |
| Aug 11, 2022 | Z-1733-2022 | — | open, classified | Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear. |
| Aug 11, 2022 | Z-1725-2022 | — | open, classified | Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear. |
| Aug 11, 2022 | Z-1729-2022 | — | open, classified | Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear. |
| Aug 11, 2022 | Z-1730-2022 | — | open, classified | Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear. |
| Aug 11, 2022 | Z-1734-2022 | — | open, classified | Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear. |
| Aug 11, 2022 | Z-1728-2022 | — | open, classified | Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear. |
| Aug 11, 2022 | Z-1727-2022 | — | open, classified | Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear. |
| Aug 11, 2022 | Z-1732-2022 | — | open, classified | Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear. |
| Aug 11, 2022 | Z-1731-2022 | — | open, classified | Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear. |
| Aug 30, 2021 | Z-0027-2022 | — | open, classified | Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. |
| Aug 30, 2021 | Z-0022-2022 | — | open, classified | Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. |
| Aug 30, 2021 | Z-0021-2022 | — | open, classified | Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. |
| Aug 30, 2021 | Z-0026-2022 | — | open, classified | Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. |
| Aug 30, 2021 | Z-0020-2022 | — | open, classified | Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. |
| Aug 30, 2021 | Z-0019-2022 | — | open, classified | Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. |
| Aug 30, 2021 | Z-0024-2022 | — | open, classified | Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. |
| Aug 30, 2021 | Z-0025-2022 | — | open, classified | Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. |
| Aug 30, 2021 | Z-0023-2022 | — | open, classified | Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. |
| Jun 29, 2021 | Z-2131-2021 | — | open, classified | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. |
| Jun 29, 2021 | Z-2127-2021 | — | open, classified | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. |
| Jun 29, 2021 | Z-2113-2021 | — | open, classified | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. |
| Jun 29, 2021 | Z-2126-2021 | — | open, classified | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. |
| Jun 29, 2021 | Z-2118-2021 | — | open, classified | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. |
| Jun 29, 2021 | Z-2112-2021 | — | open, classified | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. |
| Jun 29, 2021 | Z-2130-2021 | — | open, classified | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. |
| Jun 29, 2021 | Z-2120-2021 | — | open, classified | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. |
| Jun 29, 2021 | Z-2119-2021 | — | open, classified | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. |
| Jun 29, 2021 | Z-2133-2021 | — | open, classified | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. |
| Jun 29, 2021 | Z-2123-2021 | — | open, classified | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. |
| Jun 29, 2021 | Z-2121-2021 | — | open, classified | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. |
| Jun 29, 2021 | Z-2114-2021 | — | open, classified | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. |
| Jun 29, 2021 | Z-2132-2021 | — | open, classified | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. |
| Jun 29, 2021 | Z-2124-2021 | — | open, classified | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. |
| Jun 29, 2021 | Z-2129-2021 | — | open, classified | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. |
| Jun 29, 2021 | Z-2122-2021 | — | open, classified | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. |
| Jun 29, 2021 | Z-2115-2021 | — | open, classified | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. |
| Jun 29, 2021 | Z-2116-2021 | — | open, classified | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. |
| Jun 29, 2021 | Z-2250-2021 | — | completed | 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). |
| Jun 29, 2021 | Z-2128-2021 | — | open, classified | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. |
| Jun 29, 2021 | Z-2117-2021 | — | open, classified | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. |
| Jun 29, 2021 | Z-2125-2021 | — | open, classified | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. |
| Jun 29, 2021 | Z-2251-2021 | — | completed | 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). |
| May 11, 2021 | Z-1977-2021 | — | completed | The HAT trial contains a retaining ring that has shown the potential to disengage during use. |
| Nov 9, 2020 | Z-0884-2021 | — | open, classified | Potential for incorrect Instructions For Use (IFU) included with an Equinoxe Humeral Stem, Primary, Press Fit, 11mm package. |
| Oct 6, 2020 | Z-0459-2021 | — | terminated | The product may be mislabeled. |
| Oct 6, 2020 | Z-0460-2021 | — | terminated | The product may be mislabeled. |