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Sign in to claim this brandExactech, Inc.
United States·US-MF-000017730
Last updated September 17, 2026
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 15 of 210| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Epic Foot Plate System | A | FDA UDI | Class II | Active |
| Epic Cannulated Screw System | A | FDA UDI | Class II | Active |
| AcuMatch | 711-05-99 | FDA UDI | Class I | Active |
| Equinoxe | 321-10-11 | FDA UDI | Class I | Active |
| Equinoxe | 315-27-12 | FDA UDI | Class II | Active |
| Alteon | 189-13-09 | FDA UDI | Class I | Active |
| Equinoxe | 531-55-09 | FDA UDI | Class II | Unknown |
| Vantage | 03-PML-30-0001 | FDA UDI | Class II | Active |
| Vantage | 03-PMR-10-0001 | FDA UDI | Class II | Active |
| Optetrak Logic | 02-019-01-6042 | FDA UDI | Class I | Active |
| Equinoxe | 320-20-18 | FDA UDI | Class II | Active |
| Alteon | 01-031-00-0866 | FDA UDI | Class I | Active |
| Optetrak Logic | 02-011-06-0750 | FDA UDI | Class I | Active |
| Optetrak | 204-51-15 | FDA UDI | Class II | Active |
| Equinoxe | 308-10-05 | FDA UDI | Class II | Active |
| Equinoxe | 309-05-29 | FDA UDI | Class I | Active |
| Equinoxe | 300-30-14 | FDA UDI | Class II | Active |
| Vantage®, Activit-E | 351-24-64 | FDA UDI | Class I | Active |
| Acudriver | 400-99-00 | FDA UDI | Class I | Active |
| Optetrak Logic | 02-012-48-1511 | FDA UDI | Class II | Active |
| Optetrak Logic | 02-012-45-4050 | FDA UDI | Class II | Active |
| Optetrak | 204-06-01 | FDA UDI | Class II | Active |
| Equinoxe | 321-24-00 | FDA UDI | Class I | Active |
| Vantage | 03-PNB-CB-0005 | FDA UDI | Class II | Active |
| Vantage | 351-22-44 | FDA UDI | Class I | Active |
| Equinoxe | 301-09-20 | FDA UDI | Class II | Active |
| Equinoxe | 340-38-47 | FDA UDI | Class II | Active |
| Epic | 2000-4542 | FDA UDI | Class II | Active |
| Optetrak Logic | 02-012-61-2000 | FDA UDI | Class II | Active |
| Vantage®, Activit-E | 350-24-33 | FDA UDI | Class II | Active |
| Equinoxe | 342-38-47 | FDA UDI | Class II | Active |
| Optetrak Logic | 02-012-44-1013 | FDA UDI | Class II | Active |
| Equinoxe | 311-07-05 | FDA UDI | Class II | Active |
| Equinoxe | 304-23-07 | FDA UDI | Class II | Active |
| Optetrak Unicondylar | 250-01-06 | FDA UDI | Class II | Unknown |
| Novation | 181-00-64 | FDA UDI | Class I | Active |
| Optetrak Logic | 02-011-03-0300 | FDA UDI | Class I | Active |
| Equinoxe | 317-01-07 | FDA UDI | Class I | Active |
| Equinoxe | 315-53-05 | FDA UDI | Class I | Active |
| Equinoxe | 319-00-11 | FDA UDI | Class II | Active |
| Equinoxe | SPI-005669 | FDA UDI | Class II | Active |
| Equinoxe® | 321-19-15 | FDA UDI | Class II | Active |
| Vantage | 03-LML-10-0004 | FDA UDI | Class II | Active |
| Epic | 2000-5565 | FDA UDI | Class II | Active |
| Equinoxe | 321-98-07 | FDA UDI | Class II | Active |
| Equinoxe | 321-01-11 | FDA UDI | Class I | Active |
| Epic Cannulated Screw System | A | FDA UDI | Class II | Active |
| Epic Cannulated Screw System | A | FDA UDI | Class II | Active |
| Epic | 2000-4554 | FDA UDI | Class II | Active |
| Vantage | 03-PML-30-0003 | 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.
| 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. |