Equinoxe
Drill Guide, Small Glenoid Plate, Superior/Posterior Augment, Right
9manufacturers in China registered for this device type
442catalogue numbers in this listing
8510(k) clearances naming this product code
23recalls on this code
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (3), Zhejiang (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Stryker Trauson (Changzhou) Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 3 |
| 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 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Exactech, Inc., United States |
|---|---|
| FDA product code | KWS |
| Device type | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3660 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K140063 |
| Record published | 2015-10-30 |
| Record revised | 2025-03-06 (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 |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Sizes | Outer diameter 4.5 to 53 mm; angle 8 to 135 °; height 1.5 to 7 mm; length 54 to 215 mm; lumen/inner diameter 36 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 310-00-47 | extra-short (height) | In distribution |
| 314-06-24 | Large (size) | In distribution |
| 322-10-15 | +15mm | In distribution |
| 320-00-21 | 0 mm | In distribution |
| 301-19-12 | Outer Diameter 12 mm | In distribution |
| 314-02-15 | In distribution | |
| 314-02-34 | In distribution | |
| 320-00-02 | 0 mm | In distribution |
| 310-03-53 | In distribution | |
| 304-21-09 | Outer Diameter 8.5 mm | In distribution |
| 301-09-50 | Outer Diameter 50 mm | In distribution |
| 314-01-13 | medium (size) | In distribution |
| 322-38-03 | 38mm | In distribution |
| 302-01-10 | Outer Diameter 10 mm | In distribution |
| 315-98-30 | In distribution | |
| 315-98-29 | In distribution | |
| 315-50-10 | In distribution | |
| 331-01-04 | In distribution | |
| 315-07-06 | In distribution | |
| SPI-009732 | In distribution | |
| 315-45-11 | In distribution | |
| 310-02-41 | In distribution | |
| 315-30-03 | MEDIUM | In distribution |
| 322-10-10 | +10mm | In distribution |
| 300-10-45 | 4.5mm offset | In distribution |
| 314-04-25 | left | In distribution |
| 314-13-33 | Right | In distribution |
| 311-01-13 | In distribution | |
| 314-04-32 | Small (size) | In distribution |
| 301-17-14 | Outer Diameter 14 mm | In distribution |
| SPI-047154 | In distribution | |
| 321-35-08 | RIGHT | In distribution |
| 331-07-10 | In distribution | |
| 300-10-45 | 4.5mm offset | In distribution |
| 314-13-04 | In distribution | |
| 331-00-07 | Outer Diameter 7 mm | In distribution |
| 320-05-11 | Height 5 mm | In distribution |
| 319-24-00 | In distribution | |
| 314-02-24 | In distribution | |
| 315-27-18 | In distribution | |
| 301-09-01 | In distribution | |
| 320-05-21 | Height 5 mm | In distribution |
| 321-35-42 | Outer Diameter 42 mm | In distribution |
| 320-00-01 | 0 mm | In distribution |
| 314-01-13 | In distribution | |
| 331-11-38 | Outer Diameter 38 mm | In distribution |
| 310-02-41 | tall (height) | In distribution |
| 315-35-15 | EXTRA LARGE | In distribution |
| 331-11-01 | In distribution | |
| 301-16-41 | In distribution | |
| 301-01-15 | Outer Diameter 15 mm | In distribution |
| 315-17-03 | MEDIUM | In distribution |
| 320-20-02 | In distribution | |
| 300-21-00 | 0mm offset | In distribution |
| 314-13-13 | Beta curvature | In distribution |
| 301-15-13 | Outer Diameter 13 mm | In distribution |
| 310-01-53 | In distribution | |
| 314-02-34 | 8 degree augment | In distribution |
| 315-27-23 | MEDIUM | In distribution |
| 315-60-02 | In distribution | |
| 314-25-33 | In distribution | |
| 305-99-10 | In distribution | |
| 301-01-12 | Outer Diameter 12 mm | In distribution |
| 315-28-14 | In distribution | |
| 314-04-24 | Large (size) | In distribution |
| 301-17-07 | Outer Diameter 7 mm | In distribution |
| 304-23-07 | Length 200 mm | In distribution |
| 320-20-54 | Outer Diameter 4.5 mm | In distribution |
| 315-27-13 | In distribution | |
| 315-58-04 | In distribution | |
| 315-37-15 | Angle 8 ° | In distribution |
| 314-13-22 | 8 degree augment | In distribution |
| 314-02-25 | Extra-Large (size) | In distribution |
| 314-02-24 | 8 degree augment | In distribution |
| 300-01-16 | 16mm Diameter | In distribution |
| 331-00-03 | In distribution | |
| 321-15-42 | In distribution | |
| 314-13-34 | 8 degree augment | In distribution |
| 315-07-03 | MEDIUM | In distribution |
| 330-42-03 | 42mm + 2.5mm | In distribution |
| 320-15-03 | Left | In distribution |
| 321-15-48 | In distribution | |
| 315-30-02 | SMALL | In distribution |
| 331-11-44 | Outer Diameter 44 mm | In distribution |
| 315-07-60 | In distribution | |
| 301-18-14 | Outer Diameter 14 mm | In distribution |
| 315-45-12 | SMALL | In distribution |
| 301-11-47 | Outer Diameter 47 mm | In distribution |
| 314-24-35 | In distribution | |
| 315-60-04 | In distribution | |
| 315-27-34 | RIGHT | In distribution |
| SPI-009726 | In distribution | |
| 310-01-44 | In distribution | |
| SPI-039507 | MEDIUM | In distribution |
| 315-29-14 | In distribution | |
| 315-57-07 | In distribution | |
| 311-05-01 | In distribution | |
| 320-20-01 | In distribution | |
| 315-25-14 | In distribution | |
| 301-07-60 | SMALL | In distribution |
| 322-42-03 | 42mm | In distribution |
| 314-02-33 | In distribution | |
| 315-29-32 | SMALL | In distribution |
| 301-01-14 | Outer Diameter 14 mm | In distribution |
| 301-19-17 | Outer Diameter 17 mm | In distribution |
| 301-01-19 | Outer Diameter 19 mm | In distribution |
| 315-05-03 | MEDIUM | In distribution |
| 314-13-32 | 8 degree augment | In distribution |
| 314-06-34 | Large (size) | In distribution |
| 331-11-50 | Outer Diameter 50 mm | In distribution |
| 304-01-12 | Left | In distribution |
| 314-06-25 | Left | In distribution |
| 311-21-02 | In distribution | |
| 310-00-44 | Outer Diameter 44 mm | In distribution |
| 311-21-11 | Height 1.5 mm | In distribution |
| 315-57-18 | In distribution | |
| 315-52-11 | In distribution | |
| 315-27-12 | In distribution | |
| 314-06-33 | Right | In distribution |
| 300-01-12 | 12mm Diameter | In distribution |
| 304-03-07 | Length 200 mm | In distribution |
| 315-98-12 | MEDIUM | In distribution |
| SPI-008726 | In distribution | |
| 314-04-22 | 12 degree augment | In distribution |
| 300-01-19 | Outer Diameter 19 mm | In distribution |
| 301-09-12 | In distribution | |
| 314-24-24 | In distribution | |
| 301-01-07 | Outer Diameter 7 mm | In distribution |
| 320-05-22 | Height 5 mm | In distribution |
| 314-26-32 | In distribution | |
| 314-26-34 | In distribution | |
| 315-55-15 | EXTRA LARGE | In distribution |
| 314-25-24 | In distribution | |
| 315-30-15 | EXTRA LARGE | In distribution |
| 310-02-47 | tall (height) | In distribution |
| 315-07-02 | SMALL | In distribution |
| 315-27-17 | In distribution | |
| 315-29-24 | LARGE | In distribution |
| 301-17-13 | Outer Diameter 13 mm | In distribution |
| 315-09-04 | SMALL | In distribution |
| 314-26-24 | In distribution | |
| 301-03-10 | In distribution | |
| SPI-004305 | In distribution | |
| 315-29-15 | In distribution | |
| 314-04-35 | Right | In distribution |
| 309-07-01 | In distribution | |
| 319-28-00 | In distribution | |
| 300-50-45 | 4.5 mm offset | In distribution |
| 314-25-34 | In distribution | |
| 301-01-10 | Outer Diameter 10 mm | In distribution |
| 300-01-15 | Outer Diameter 15 mm | In distribution |
| 314-13-14 | In distribution | |
| 314-13-25 | Left | In distribution |
| 310-03-47 | In distribution | |
| 321-35-38 | Outer Diameter 38 mm | In distribution |
| 314-02-04 | In distribution | |
| 314-25-22 | In distribution | |
| 315-30-13 | MEDIUM | In distribution |
| 314-02-13 | medium (size) | In distribution |
| 300-21-15 | 1.5mm offset | In distribution |
| 305-07-10 | In distribution | |
| 314-13-02 | Small (size) | In distribution |
| 314-06-32 | Small (size) | In distribution |
| 321-17-33 | In distribution | |
| 314-26-33 | In distribution | |
| 314-02-12 | In distribution | |
| 315-58-02 | In distribution | |
| 324-40-03 | +2.5mm | In distribution |
| 301-21-47 | Outer Diameter 47 mm | In distribution |
| 315-58-12 | In distribution | |
| 315-26-21 | In distribution | |
| 315-50-01 | EXTRA SMALL | In distribution |
| 314-24-33 | In distribution | |
| 315-52-01 | In distribution | |
| 301-18-09 | Outer Diameter 9 mm | In distribution |
| 310-00-53 | 53mm Diameter | In distribution |
| 315-27-32 | SMALL | In distribution |
| 301-11-11 | In distribution | |
| 301-05-13 | Outer Diameter 13 mm | In distribution |
| 315-51-04 | LARGE | In distribution |
| 321-60-01 | In distribution | |
| 315-17-60 | In distribution | |
| 314-04-33 | Right | In distribution |
| 315-58-11 | In distribution | |
| 331-00-14 | Outer Diameter 14 mm | In distribution |
| 301-21-53 | Outer Diameter 53 mm | In distribution |
| 305-05-13 | Outer Diameter 13 mm | In distribution |
| 301-99-33 | LARGE | In distribution |
| 331-03-01 | In distribution | |
| 322-44-03 | +2.5mm | In distribution |
| 310-01-53 | short (height) | In distribution |
| 315-98-23 | In distribution | |
| 315-37-14 | Angle 8 ° | In distribution |
| SPI-009725 | In distribution | |
| 301-30-07 | Outer Diameter 7 mm | In distribution |
| 315-52-66 | In distribution | |
| 315-27-14 | In distribution | |
| 315-27-15 | In distribution | |
| 321-37-32 | In distribution | |
| 315-26-03 | MEDIUM | In distribution |
| 301-13-38 | Outer Diameter 38 mm | In distribution |
| 320-05-02 | Height 5 mm | In distribution |
| 314-06-22 | Small (size) | In distribution |
| 315-09-06 | In distribution | |
| 314-13-15 | In distribution | |
| 301-99-67 | In distribution | |
| 315-28-12 | In distribution | |
| 315-29-13 | In distribution | |
| 311-01-20 | In distribution | |
| 331-01-03 | In distribution | |
| 301-08-60 | LARGE | In distribution |
| 315-98-10 | EXTRA SMALL | In distribution |
| 320-05-01 | Height 5 mm | In distribution |
| 314-23-15 | In distribution | |
| 311-21-12 | Height 4.5 mm | In distribution |
| SPI-009734 | In distribution | |
| 321-05-42 | Outer Diameter 42 mm | In distribution |
| 314-26-23 | In distribution | |
| 301-15-19 | Outer Diameter 19 mm | In distribution |
| 301-05-20 | In distribution | |
| 314-13-14 | Large (size) | In distribution |
| 320-36-03 | Lumen/Inner Diameter 36 mm | In distribution |
| 314-24-34 | In distribution | |
| 315-29-35 | Angle 16 ° | In distribution |
| 315-58-03 | In distribution | |
| 301-08-41 | MEDIUM | In distribution |
| 300-01-08 | 8mm Diameter | In distribution |
| 310-03-50 | expanded (height) | In distribution |
| 310-01-47 | short (height) | In distribution |
| 311-09-01 | In distribution | |
| 322-36-13 | 36mm | In distribution |
| 314-25-23 | In distribution | |
| 301-01-09 | Outer Diameter 9 mm | In distribution |
| 314-04-23 | left | In distribution |
| 314-02-13 | In distribution | |
| 314-02-03 | medium (size) | In distribution |
| 301-19-13 | Outer Diameter 13 mm | In distribution |
| 315-50-00 | In distribution | |
| 315-58-10 | In distribution | |
| 315-45-13 | MEDIUM | In distribution |
| 314-23-14 | In distribution | |
| 314-25-35 | In distribution | |
| 315-55-14 | LARGE | In distribution |
| 315-29-33 | MEDIUM | In distribution |
| 301-30-13 | Outer Diameter 13 mm | In distribution |
| 321-35-46 | Outer Diameter 46 mm | In distribution |
| 314-13-04 | Large (size) | In distribution |
| 315-09-05 | MEDIUM/LARGE | In distribution |
| 321-25-46 | Outer Diameter 46 mm | In distribution |
| 315-26-01 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Reunion | Stryker GmbH | 321 |
| DJO Surgical | Encore Medical, L.P. | 266 |
| SMR Shoulder | Limacorporate | 209 |
| Tornier Flex Shoulder System | Tornier Inc. | 187 |
| Anatomical Shoulder™ | Zimmer, Inc. | 166 |
| Arthrex® | Arthrex, Inc. | 154 |
| Comprehensive Shoulder System | Biomet Orthopedics | 111 |
| Flex Shoulder System | Tornier Inc. | 109 |
| Aequalis™ PerFORM+ | Tornier Inc. | 108 |
| Aequalis™ Ascend™ Flex | Tornier Inc. | 102 |
| Anatomic Shoulder Prosthesis | Medacta International SA | 90 |
| Cofield | Smith & Nephew, Inc. | 76 |
Showing 12 of 326. All products under Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K212356 | 2022-03-04 |
| K140063 | 2014-02-11 |
| K121220 | 2012-11-20 |
| K113309 | 2011-12-08 |
| K111379 | 2011-06-08 |
| K103419 | 2010-12-13 |
| K093430 | 2010-09-02 |
| K042021 | 2004-10-26 |
Recalls Naming This Product
50 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 | 805 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 | 985 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 | 35 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 | 39 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 | 180 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 | 245 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 | 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. | UDI-DI | 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 |
Showing 40 of 50.
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.