Equinoxe
Special Glenosphere Inserter with Rotational Control Feature
6manufacturers in China registered for this device type
336catalogue numbers in this listing
4510(k) clearances naming this product code
5recalls on this code
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (2), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Exactech, Inc., United States |
|---|---|
| FDA product code | KWT |
| Device type | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3650 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K063569 |
| Record published | 2022-08-18 |
| Record revised | 2019-08-28 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Sizes | Outer diameter 2 to 53 mm; lumen/inner diameter 36 to 46 mm; length 12.5 to 200 mm; angle 8 to 135 °; circumference 6 to 46 mm; height 5 to 15 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 321-09-42 | Outer Diameter 42 mm | In distribution |
| 321-52-33 | In distribution | |
| 321-45-42 | Outer Diameter 42 mm | In distribution |
| 308-08-12 | Size Extra Small | In distribution |
| 315-29-42 | In distribution | |
| 321-01-20 | In distribution | |
| 321-50-42 | Outer Diameter 42 mm | In distribution |
| 315-98-57 | In distribution | |
| 324-44-10 | Angle 135 ° | In distribution |
| 300-30-08 | Circumference 8 mm | In distribution |
| 324-46-00 | 46mm | In distribution |
| 321-01-32 | In distribution | |
| 315-57-08 | In distribution | |
| 321-09-10 | In distribution | |
| 315-31-43 | In distribution | |
| 315-17-10 | In distribution | |
| SPI-009731 | In distribution | |
| 321-16-35 | In distribution | |
| 321-01-51 | In distribution | |
| 301-30-09 | Outer Diameter 9 mm | In distribution |
| 321-10-35 | In distribution | |
| 301-16-38 | Height 0 | In distribution |
| 320-01-42 | Outer Diameter 42 mm | In distribution |
| 301-10-38 | Outer Diameter 38 mm | In distribution |
| 331-25-15 | EXTRA LARGE | In distribution |
| 315-55-13 | MEDIUM | In distribution |
| 321-03-42 | RIGHT | In distribution |
| 321-15-09 | In distribution | |
| 321-03-46 | Circumference 46 mm | In distribution |
| 314-01-15 | extra-large (size) | In distribution |
| 315-51-03 | MEDIUM | In distribution |
| 320-44-03 | 2.5mm offset | In distribution |
| 321-98-00 | In distribution | |
| 315-29-44 | In distribution | |
| 320-35-02 | 10 degree superior augment | In distribution |
| 324-10-00 | 0mm offset | In distribution |
| SPI-009733 | In distribution | |
| 315-59-09 | In distribution | |
| 315-54-04 | LARGE | In distribution |
| 321-07-46 | Outer Diameter 46 mm | In distribution |
| 321-19-34 | In distribution | |
| 321-55-38 | Outer Diameter 38 mm | In distribution |
| 315-98-32 | In distribution | |
| SPI-007865 | In distribution | |
| 315-27-45 | In distribution | |
| 321-15-00 | In distribution | |
| 304-21-07 | Left | In distribution |
| 321-01-29 | In distribution | |
| 315-31-45 | In distribution | |
| 315-98-33 | In distribution | |
| 315-56-03 | MEDIUM | In distribution |
| 315-52-64 | In distribution | |
| 320-01-36 | Outer Diameter 36 mm | In distribution |
| 320-15-10 | Low Profile | In distribution |
| 315-27-43 | In distribution | |
| 321-01-31 | In distribution | |
| 320-55-03 | Angle 8 ° | In distribution |
| 321-15-07 | Outer Diameter 3.2 mm | In distribution |
| 301-10-05 | In distribution | |
| 321-01-10 | In distribution | |
| 321-17-43 | In distribution | |
| 315-15-10 | In distribution | |
| 321-50-38 | Outer Diameter 38 mm | In distribution |
| 320-15-01 | In distribution | |
| SPI-045525 | In distribution | |
| 321-01-05 | In distribution | |
| 324-36-10 | 36mm | In distribution |
| 330-46-03 | 46mm + 2.5mm | In distribution |
| 321-50-01 | In distribution | |
| 321-03-38 | Circumference 38 mm | In distribution |
| 320-35-04 | 8 degree posterior augment | In distribution |
| 321-15-36 | In distribution | |
| 310-22-41 | Outer Diameter 41 mm | In distribution |
| 301-10-53 | Outer Diameter 53 mm | In distribution |
| 321-98-07 | Outer Diameter 46 mm | In distribution |
| 321-19-15 | In distribution | |
| 321-05-38 | Outer Diameter 38 mm | In distribution |
| 321-15-31 | In distribution | |
| 331-27-62 | In distribution | |
| 321-15-06 | Outer Diameter 2 mm | In distribution |
| 321-19-05 | In distribution | |
| 324-38-13 | 38mm | In distribution |
| 322-40-03 | +2.5mm | In distribution |
| 309-07-08 | In distribution | |
| 305-07-20 | In distribution | |
| 320-42-00 | 0mm offset | In distribution |
| 330-46-13 | 46mm + 2.5mm Constrained | In distribution |
| 321-98-01 | Outer Diameter 38 mm | In distribution |
| 322-46-10 | Constrained | In distribution |
| 321-01-26 | In distribution | |
| 315-31-42 | In distribution | |
| 315-05-04 | LARGE | In distribution |
| 315-55-05 | EXTRA LARGE | In distribution |
| 321-19-35 | In distribution | |
| 300-21-45 | 4.5mm offset | In distribution |
| 321-16-66 | In distribution | |
| 305-21-00 | In distribution | |
| SPI-013425 | In distribution | |
| 320-20-38 | Outer Diameter 4.5 mm | In distribution |
| 300-21-00 | 0mm offset | In distribution |
| 315-25-12 | SMALL | In distribution |
| 321-16-06 | In distribution | |
| 315-52-60 | In distribution | |
| SPI-043320 | In distribution | |
| SPI-043622 | In distribution | |
| 320-46-10 | constrained | In distribution |
| SPI-044993 | In distribution | |
| SPI-006665 | In distribution | |
| 315-07-04 | LARGE | In distribution |
| 324-42-10 | Constrained | In distribution |
| 331-27-02 | In distribution | |
| 301-99-32 | MEDIUM | In distribution |
| 321-01-30 | In distribution | |
| 320-42-03 | Lumen/Inner Diameter 42 mm | In distribution |
| 321-01-25 | In distribution | |
| 321-55-01 | In distribution | |
| 322-42-00 | +0mm | In distribution |
| 320-20-30 | Outer Diameter 4.5 mm | In distribution |
| SPI-040698 | In distribution | |
| 304-22-13 | Outer Diameter 12.5 mm | In distribution |
| 321-17-42 | In distribution | |
| 322-46-00 | 46mm | In distribution |
| 320-55-04 | Right | In distribution |
| 310-22-47 | Outer Diameter 47 mm | In distribution |
| 321-98-06 | Outer Diameter 42 mm | In distribution |
| 321-15-34 | In distribution | |
| 321-05-46 | Outer Diameter 46 mm | In distribution |
| SPI-044393 | In distribution | |
| 320-20-18 | Length 18 mm | In distribution |
| 320-31-42 | Outer Diameter 42 mm | In distribution |
| 320-31-46 | Outer Diameter 46 mm | In distribution |
| 315-50-03 | MEDIUM | In distribution |
| 321-01-28 | In distribution | |
| 322-38-00 | 38mm | In distribution |
| 321-16-05 | Height 5 mm | In distribution |
| 321-15-05 | In distribution | |
| 321-15-33 | In distribution | |
| SPI-044394 | In distribution | |
| 321-07-38 | Outer Diameter 38 mm | In distribution |
| 315-35-11 | EXTRA SMALL | In distribution |
| 315-26-11 | In distribution | |
| 321-01-57 | In distribution | |
| 321-02-42 | LEFT | In distribution |
| 321-19-11 | In distribution | |
| 315-59-02 | In distribution | |
| 320-46-00 | 0mm offset | In distribution |
| 320-42-13 | Lumen/Inner Diameter 42 mm | In distribution |
| 300-30-10 | Circumference 10 mm | In distribution |
| 322-44-00 | +0mm | In distribution |
| 321-35-23 | In distribution | |
| 310-23-53 | Outer Diameter 53 mm | In distribution |
| 320-01-38 | Outer Diameter 38 mm | In distribution |
| 321-15-03 | In distribution | |
| 320-20-50 | Length 50 mm | In distribution |
| 320-38-10 | constrained | In distribution |
| 321-35-00 | In distribution | |
| 320-31-38 | Outer Diameter 38 mm | In distribution |
| 301-30-11 | Outer Diameter 11 mm | In distribution |
| 304-24-07 | Outer Diameter 6.5 mm | In distribution |
| SPI-044391 | In distribution | |
| 321-07-10 | In distribution | |
| 321-98-02 | Outer Diameter 42 mm | In distribution |
| 321-07-42 | Outer Diameter 42 mm | In distribution |
| 301-10-41 | Outer Diameter 41 mm | In distribution |
| 331-10-30 | In distribution | |
| 321-17-44 | In distribution | |
| 320-42-10 | constrained | In distribution |
| 300-30-14 | Circumference 14 mm | In distribution |
| 320-38-13 | Lumen/Inner Diameter 38 mm | In distribution |
| 304-22-11 | Right | In distribution |
| 315-25-00 | In distribution | |
| 301-16-37 | 1.5/4.5 Height | In distribution |
| 321-15-13 | In distribution | |
| 320-20-46 | Outer Diameter 4.5 mm | In distribution |
| 304-21-11 | Left | In distribution |
| 321-50-46 | In distribution | |
| 322-42-13 | 42mm | In distribution |
| 321-05-21 | In distribution | |
| 320-32-38 | Outer Diameter 38 mm | In distribution |
| 315-31-44 | In distribution | |
| 321-02-38 | Circumference 38 mm | In distribution |
| 321-02-16 | In distribution | |
| 321-52-67 | 8, 10, 8/10 Degree | In distribution |
| 321-60-46 | In distribution | |
| SPI-044392 | In distribution | |
| SPI-044440 | In distribution | |
| 320-10-10 | 10mm offset | In distribution |
| 321-52-07 | Outer Diameter 3.2 mm | In distribution |
| 321-19-14 | In distribution | |
| 321-10-40 | In distribution | |
| 320-15-02 | 10 degree superior augment | In distribution |
| SPI-040194 | In distribution | |
| 321-52-66 | 0 Degree | In distribution |
| 321-19-04 | In distribution | |
| SPI-047577 | In distribution | |
| 321-45-38 | Outer Diameter 38 mm | In distribution |
| 320-55-98 | In distribution | |
| 315-03-02 | In distribution | |
| 319-27-00 | In distribution | |
| 315-37-12 | In distribution | |
| 321-15-04 | In distribution | |
| 320-44-13 | Constrained | In distribution |
| 331-27-05 | In distribution | |
| 305-99-12 | Height 12 mm | In distribution |
| 321-98-03 | Outer Diameter 46 mm | In distribution |
| 322-46-13 | Constrained | In distribution |
| 321-09-38 | Outer Diameter 38 mm | In distribution |
| 310-23-47 | Outer Diameter 47 mm | In distribution |
| 311-07-06 | In distribution | |
| 320-02-42 | Outer Diameter 42 mm | In distribution |
| 321-20-00 | In distribution | |
| 321-35-16 | In distribution | |
| 321-03-10 | In distribution | |
| 305-07-20 | In distribution | |
| 320-35-07 | Left | In distribution |
| 320-11-38 | Outer Diameter 38 mm | In distribution |
| 315-45-15 | EXTRA LARGE | In distribution |
| 301-13-41 | Outer Diameter 41 mm | In distribution |
| SPI-040164 | In distribution | |
| SPI-046468 | In distribution | |
| 321-01-33 | In distribution | |
| 331-25-00 | In distribution | |
| 321-01-52 | In distribution | |
| 320-46-13 | Lumen/Inner Diameter 46 mm | In distribution |
| 331-10-31 | In distribution | |
| SPI-005672 | In distribution | |
| 320-38-00 | 0mm offset | In distribution |
| 321-15-30 | In distribution | |
| 320-15-04 | 8 degree posterior augment | In distribution |
| 320-40-10 | Constrained | In distribution |
| 310-23-41 | Outer Diameter 41 mm | In distribution |
| 321-15-11 | In distribution | |
| SPI-005668 | In distribution | |
| 315-37-12 | Angle 8 ° | In distribution |
| 315-35-14 | LARGE | In distribution |
| 320-20-42 | Length 42 mm | In distribution |
| SPI-047576 | In distribution | |
| 310-21-47 | Outer Diameter 47 mm | In distribution |
| 315-57-17 | In distribution | |
| 315-29-43 | In distribution | |
| 331-27-07 | In distribution | |
| 304-22-07 | Right | In distribution |
| 315-98-03 | MEDIUM | In distribution |
| SPI-040192 | In distribution | |
| SPI-045324 | In distribution | |
| 320-20-00 | In distribution | |
| 321-02-46 | Circumference 46 mm | In distribution |
| 310-11-44 | short (height) | In distribution |
| 321-15-02 | In distribution | |
| 320-15-05 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| SMR Shoulder | Limacorporate | 289 |
| Tornier Perform Humeral System | Tornier Inc. | 119 |
| Bigliani/Flatow® | Zimmer, Inc. | 119 |
| Trabecular Metal® | Zimmer, Inc. | 115 |
| Jarvis Glenoid Rerverse Shoulder Prosthesis | Fournitures Hospitalieres Industrie | 103 |
| Comprehensive® Shoulder System | Biomet Orthopedics | 86 |
| Alliance® | Zimmer, Inc. | 68 |
| Anatomical Shoulder™ | Zimmer, Inc. | 54 |
| Aetos Shoulder System | Smith & Nephew, Inc. | 53 |
| Perform™ Humeral System | Tornier Inc. | 47 |
| Bio-Modular® Shoulder System | Biomet Orthopedics | 43 |
| Catalyst CSR Shoulder System | Catalyst Orthoscience Inc | 39 |
Showing 12 of 164. All products under Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K250713 | 2025-12-01 |
| K162903 | 2017-02-27 |
| K143659 | 2015-04-09 |
| K110706 | 2011-05-17 |
Recalls Naming This Product
45 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Exactech, Inc. | 510(k) number | 2025-09-05 | Class II | Release of Material/Component prior to receiving test results | Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria. | 1 | |
| Exactech, Inc. | 510(k) number | 2025-09-05 | Class II | Release of Material/Component prior to receiving test results | Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria. | 1 | |
| Exactech, Inc. | 510(k) number | 2025-09-05 | Class II | Release of Material/Component prior to receiving test results | Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria. | 1 | |
| Exactech, Inc. | 510(k) number | 2025-08-15 | Class II | Process design | Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling. | 61,334 UNITS | |
| Exactech, Inc. | 510(k) number | 2025-08-15 | Class II | Process design | Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling. | 11,542 units | |
| Exactech, Inc. | 510(k) number | 2024-03-06 | Class II | Nonconforming Material/Component | 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 cons | 2077 units | |
| Exactech, Inc. | 510(k) number | 2024-03-06 | Class II | Nonconforming Material/Component | 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 cons | 2008 units | |
| Exactech, Inc. | 510(k) number | 2024-03-06 | Class II | Nonconforming Material/Component | 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 cons | 6678 units | |
| Exactech, Inc. | 510(k) number | 2024-03-06 | Class II | Nonconforming Material/Component | 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 cons | 6840 units | |
| Exactech, Inc. | 510(k) number | 2024-03-06 | Class II | Nonconforming Material/Component | 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 cons | 11031 units | |
| Exactech, Inc. | 510(k) number | 2024-03-06 | Class II | Nonconforming Material/Component | 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 cons | 12643 units | |
| Exactech, Inc. | 510(k) number | 2024-03-06 | Class II | Nonconforming Material/Component | 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 cons | 3436 units | |
| Exactech, Inc. | 510(k) number | 2024-03-06 | Class II | Nonconforming Material/Component | 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 cons | 4007 units | |
| Exactech, Inc. | UDI-DI | 2024-03-06 | Class II | Nonconforming Material/Component | 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 cons | 11863 units | |
| Exactech, Inc. | UDI-DI | 2024-03-06 | Class II | Nonconforming Material/Component | 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 cons | 826 units | |
| Exactech, Inc. | 510(k) number | 2024-03-06 | Class II | Nonconforming Material/Component | 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 cons | 66646 units | |
| Exactech, Inc. | 510(k) number | 2024-03-06 | Class II | Nonconforming Material/Component | 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 cons | 7213 units | |
| Exactech, Inc. | 510(k) number | 2024-03-06 | Class II | Nonconforming Material/Component | 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 cons | 2806 units | |
| Exactech, Inc. | 510(k) number | 2024-03-06 | Class II | Nonconforming Material/Component | 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 cons | 447 units | |
| Exactech, Inc. | 510(k) number | 2024-03-06 | Class II | Nonconforming Material/Component | 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 cons | 24303 units | |
| Exactech, Inc. | 510(k) number | 2024-03-06 | Class II | Nonconforming Material/Component | 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 cons | 3648 units | |
| Exactech, Inc. | 510(k) number | 2024-03-06 | Class II | Nonconforming Material/Component | 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 cons | 1970 units | |
| Exactech, Inc. | 510(k) number | 2024-03-06 | Class II | Nonconforming Material/Component | 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 cons | 591 units | |
| Exactech, Inc. | 510(k) number | 2023-11-21 | Class II | Packaging change control | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. | ||
| Exactech, Inc. | 510(k) number | 2021-05-11 | Class II | Device Design | The HAT trial contains a retaining ring that has shown the potential to disengage during use. | 36 devices | |
| Exactech, Inc. | 510(k) number | 2020-11-09 | Class II | Employee error | Potential for incorrect Instructions For Use (IFU) included with an Equinoxe Humeral Stem, Primary, Press Fit, 11mm package. | 14 devices | |
| Exactech, Inc. | 510(k) number | 2020-10-06 | Class II | Packaging process control | The product may be mislabeled. | 69 devices | 2023-11-13 |
| Exactech, Inc. | 510(k) number | 2020-10-06 | Class II | Packaging process control | The product may be mislabeled. | 40 devices | 2023-11-13 |
| Exactech, Inc. | 510(k) number | 2020-09-25 | Class II | Process control | The device may be incorrectly laser marked as a right stem, when it should have been laser marked as a left stem. | 25 devices | 2023-05-01 |
| Exactech, Inc. | 510(k) number | 2020-09-25 | Class II | Process control | The device may be incorrectly laser marked as a right stem, when it should have been laser marked as a left stem. | 12 devices | 2023-05-01 |
| Exactech, Inc. | 510(k) number | 2020-08-24 | Class II | Labeling Change Control | Exactech is recalling the Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit, because it may contain a incorrect length screw. | 125 devices | 2023-05-01 |
| Exactech, Inc. | 510(k) number | 2020-08-24 | Class II | Labeling Change Control | Exactech is recalling the Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit, because it may contain a incorrect length screw. | 149 devices | 2023-05-01 |
| Exactech, Inc. | 510(k) number | 2019-12-03 | Class II | Under Investigation by firm | Labels with incorrect translations were identified by Exactech is a distributor in the Netherlands. The translations on the outer labels include the word ” long” in all languages other than the original English version. The implants are | 2,910 devices | 2022-10-11 |
| Exactech, Inc. | 510(k) number | 2019-12-03 | Class II | Under Investigation by firm | Labels with incorrect translations were identified by Exactech is a distributor in the Netherlands. The translations on the outer labels include the word ” long” in all languages other than the original English version. The implants are | 2022-10-11 | |
| Exactech, Inc. | 510(k) number | 2018-12-05 | Class II | Packaging | Possibility that the Equinoxe Preserve Humeral Stem, 8mm, was inadvertently packaged with an Optetrak Knee System instructions for use (IFU) rather than the Equinoxe Preserve Humeral Stem IFU as intended. | 40 devices | 2021-04-29 |
| Exactech, Inc. | 510(k) number | 2018-08-21 | Class II | Under Investigation by firm | The Equinoxe Reverse Drill Bit Kits may contain two 2mm diameter drill bits instead of one 2mm diameter drill bit and one 3.2mm diameter drill bit as intended. | 2 units | |
| Exactech, Inc. | 510(k) number | 2017-08-31 | Class II | Under Investigation by firm | Potentially mislabeled. | 30 | 2019-08-06 |
| Exactech, Inc. | 510(k) number | 2017-08-31 | Class II | Under Investigation by firm | Potentially mislabeled. | 30 | 2019-08-06 |
| Exactech, Inc. | 510(k) number | 2016-10-25 | Class II | Component design/selection | Disengaged screw head could potentially not be retained in the Torque Defining Screwdriver. | 2,278 units | 2019-07-26 |
| Exactech, Inc. | 510(k) number | 2015-02-13 | Class II | Labeling mix-ups | Incorrectly packaged. Outer and inner labeling may incorrectly identify the size of the enclosed device. | 112 devices | 2016-09-29 |
Showing 40 of 45.
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.