Equinoxe
Glenoid, Posterior Augment Pegged, 8 degree, Cemented Right
8manufacturers in China registered for this device type
345catalogue numbers in this listing
4510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Shanghai (3), Jiangsu (3), Zhejiang (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| 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 |
| 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 | HSD |
| Device type | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3690 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K121067 |
| Record published | 2015-10-30 |
| Record revised | 2024-02-19 (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 6 to 53 mm; length 0 to 200 mm; angle 132.5 ° |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 300-30-00 | In distribution | |
| 313-07-01 | In distribution | |
| 301-11-44 | Outer Diameter 44 mm | In distribution |
| 308-02-09 | Outer Diameter 9 mm | In distribution |
| 313-25-44 | Outer Diameter 44 mm | In distribution |
| 308-05-27 | Outer Diameter 27.5 mm | In distribution |
| 309-15-08 | Outer Diameter 8 mm | In distribution |
| 310-01-47 | In distribution | |
| 313-07-01 | In distribution | |
| SPI-005667 | In distribution | |
| 315-60-03 | In distribution | |
| 310-21-44 | short (height) | In distribution |
| 300-51-45 | 4.5 mm offset | In distribution |
| 308-02-08 | Length 120 mm | In distribution |
| 321-35-01 | In distribution | |
| 301-21-44 | Outer Diameter 44 mm | In distribution |
| 310-21-50 | short (height) | In distribution |
| 308-10-05 | Length 0 mm | In distribution |
| 310-22-38 | tall (height) | In distribution |
| 310-02-38 | In distribution | |
| 311-01-11 | In distribution | |
| 315-26-05 | EXTRA LARGE | In distribution |
| 308-05-20 | Outer Diameter 20.5 mm | In distribution |
| 313-10-53 | Outer Diameter 53 mm | In distribution |
| 312-01-02 | Length 30 mm | In distribution |
| 308-12-00 | Size Medium | In distribution |
| 301-19-09 | Outer Diameter 9 mm | In distribution |
| 315-98-13 | LARGE | In distribution |
| 306-02-10 | Length 200 mm | In distribution |
| SPI-009106 | In distribution | |
| 315-27-04 | In distribution | |
| 309-07-04 | In distribution | |
| 313-25-44 | Outer Diameter 44 mm | In distribution |
| 308-15-37 | Size 37.5 | In distribution |
| 310-22-44 | tall (height) | In distribution |
| 301-12-50 | Outer Diameter 50 mm | In distribution |
| 309-07-10 | In distribution | |
| 315-55-04 | LARGE | In distribution |
| 331-01-12 | In distribution | |
| 306-01-08 | Length 175 mm | In distribution |
| 312-01-38 | Outer Diameter 38 mm | In distribution |
| SPI-005669 | In distribution | |
| 301-05-02 | In distribution | |
| 300-01-10 | 10mm Diameter | In distribution |
| SPI-039508 | LARGE | In distribution |
| 313-25-47 | Outer Diameter 47 mm | In distribution |
| 301-05-01 | In distribution | |
| 300-10-15 | 1.55mm offset | In distribution |
| 301-17-15 | Outer Diameter 15 mm | In distribution |
| 315-98-04 | LARGE | In distribution |
| 300-01-14 | 14mm Diameter | In distribution |
| 308-15-50 | Size 50 | In distribution |
| 315-27-02 | In distribution | |
| 314-01-03 | In distribution | |
| 320-30-00 | In distribution | |
| 308-12-05 | Length 12.5 mm | In distribution |
| 314-02-02 | In distribution | |
| 313-07-02 | In distribution | |
| 313-10-50 | Outer Diameter 50 mm | In distribution |
| 308-16-37 | Size 137.5 | In distribution |
| 300-51-00 | 0 mm offset | In distribution |
| 308-16-25 | Size 125 | In distribution |
| 315-27-06 | In distribution | |
| 309-15-11 | Outer Diameter 11 mm | In distribution |
| 315-05-02 | SMALL | In distribution |
| 301-17-12 | Outer Diameter 12 mm | In distribution |
| 315-25-03 | MEDIUM | In distribution |
| 314-02-02 | Pegged | In distribution |
| 301-12-53 | Extra SMALL | In distribution |
| SPI-005666 | In distribution | |
| 301-30-06 | Outer Diameter 6 mm | In distribution |
| 308-01-07 | Outer Diameter 7 mm | In distribution |
| 312-01-53 | Outer Diameter 53 mm | In distribution |
| 308-15-01 | Size 0 | In distribution |
| 315-98-21 | In distribution | |
| 321-59-42 | In distribution | |
| 314-02-12 | Pegged | In distribution |
| 301-11-50 | Outer Diameter 50 mm | In distribution |
| 308-02-13 | Outer Diameter 13 mm | In distribution |
| 315-15-03 | MEDIUM | In distribution |
| 309-15-12 | Outer Diameter 12 mm | In distribution |
| 313-10-50 | Outer Diameter 50 mm | In distribution |
| 310-02-44 | alpha curvature | In distribution |
| 314-13-33 | In distribution | |
| 315-98-25 | In distribution | |
| 315-37-14 | In distribution | |
| 313-10-41 | Outer Diameter 41 mm | In distribution |
| 308-01-09 | Outer Diameter 9 mm | In distribution |
| 313-05-10 | In distribution | |
| 304-01-10 | Outer Diameter 9.5 mm | In distribution |
| 309-15-06 | Outer Diameter 6 mm | In distribution |
| 301-17-10 | Outer Diameter 10 mm | In distribution |
| 315-26-04 | LARGE | In distribution |
| 308-01-13 | Outer Diameter 13 mm | In distribution |
| 315-17-02 | SMALL | In distribution |
| 313-25-38 | Outer Diameter 38 mm | In distribution |
| 321-15-23 | In distribution | |
| 311-01-12 | In distribution | |
| 308-01-08 | Length 80 mm | In distribution |
| 308-05-19 | Outer Diameter 19.5 mm | In distribution |
| 301-08-61 | LARGE | In distribution |
| 331-00-09 | Outer Diameter 9 mm | In distribution |
| 308-05-32 | Outer Diameter 32.5 mm | In distribution |
| 301-18-12 | Outer Diameter 12 mm | In distribution |
| 315-51-02 | SMALL | In distribution |
| 331-00-10 | Outer Diameter 10 mm | In distribution |
| 308-15-87 | Size 87.5 | In distribution |
| 304-02-12 | Outer Diameter 12 mm | In distribution |
| 331-00-13 | Outer Diameter 13 mm | In distribution |
| 308-08-00 | Length 0 mm | In distribution |
| 315-59-00 | In distribution | |
| SPI-005671 | In distribution | |
| 315-35-13 | MEDIUM | In distribution |
| 301-09-10 | In distribution | |
| 301-15-15 | Outer Diameter 15 mm | In distribution |
| 301-11-53 | Outer Diameter 53 mm | In distribution |
| 315-25-15 | EXTRA LARGE | In distribution |
| 310-23-50 | expanded (height) | In distribution |
| 301-15-11 | Outer Diameter 11 mm | In distribution |
| 301-17-09 | Outer Diameter 9 mm | In distribution |
| 308-10-00 | Size Medium | In distribution |
| 315-37-13 | In distribution | |
| 301-12-47 | Extra SMALL | In distribution |
| 315-55-11 | EXTRA SMALL | In distribution |
| 314-02-03 | In distribution | |
| 315-57-04 | In distribution | |
| 310-01-38 | alpha curvature | In distribution |
| 308-05-26 | Outer Diameter 26.5 mm | In distribution |
| 300-10-15 | 1.5mm offset | In distribution |
| 331-01-11 | In distribution | |
| 301-10-47 | Outer Diameter 47 mm | In distribution |
| 308-15-25 | Size 25 | In distribution |
| 308-05-33 | Outer Diameter 33.5 mm | In distribution |
| 315-17-61 | In distribution | |
| 301-03-01 | In distribution | |
| 308-15-12 | Size 12.5 | In distribution |
| 313-05-01 | In distribution | |
| 300-01-09 | Outer Diameter 9 mm | In distribution |
| 314-13-13 | In distribution | |
| 315-17-20 | In distribution | |
| 313-25-50 | Outer Diameter 50 mm | In distribution |
| 331-25-14 | LARGE | In distribution |
| 311-21-01 | In distribution | |
| 331-25-13 | MEDIUM | In distribution |
| 301-15-10 | Outer Diameter 10 mm | In distribution |
| 301-01-11 | Outer Diameter 11 mm | In distribution |
| 311-07-07 | In distribution | |
| 310-21-38 | short (height) | In distribution |
| 313-01-10 | In distribution | |
| 308-09-12 | Length 12.5 mm | In distribution |
| 315-50-04 | LARGE | In distribution |
| 313-25-41 | Outer Diameter 41 mm | In distribution |
| 301-11-38 | Outer Diameter 38 mm | In distribution |
| 310-01-50 | In distribution | |
| 308-09-00 | Size Small | In distribution |
| 315-15-04 | In distribution | |
| 310-01-50 | beta curvature | In distribution |
| 313-05-02 | In distribution | |
| 305-05-11 | Outer Diameter 10.5 mm | In distribution |
| 314-01-14 | Keeled | In distribution |
| 315-57-06 | In distribution | |
| 301-19-07 | Outer Diameter 7 mm | In distribution |
| 313-07-10 | In distribution | |
| 302-01-12 | Outer Diameter 12 mm | In distribution |
| 309-01-32 | Outer Diameter 34 mm | In distribution |
| 313-07-07 | In distribution | |
| 303-30-06 | Outer Diameter 6 mm | In distribution |
| 315-98-01 | EXTRA SMALL | In distribution |
| 311-01-10 | Angle 132.5 ° | In distribution |
| 301-05-15 | Outer Diameter 15 mm | In distribution |
| 315-98-02 | SMALL | In distribution |
| 321-15-38 | In distribution | |
| 313-10-41 | Outer Diameter 41 mm | In distribution |
| SPI-010585 | In distribution | |
| 308-05-21 | Outer Diameter 21.5 mm | In distribution |
| 315-07-20 | In distribution | |
| 309-15-14 | Outer Diameter 14 mm | In distribution |
| 321-25-01 | In distribution | |
| 315-05-01 | EXTRA SMALL | In distribution |
| 313-10-38 | Outer Diameter 38 mm | In distribution |
| 313-25-53 | Outer Diameter 53 mm | In distribution |
| 311-01-14 | In distribution | |
| 301-09-11 | In distribution | |
| 301-05-11 | Outer Diameter 11 mm | In distribution |
| 309-07-12 | In distribution | |
| 321-19-25 | In distribution | |
| 308-02-07 | Outer Diameter 7 mm | In distribution |
| 310-02-38 | alpha curvature | In distribution |
| 301-18-15 | Outer Diameter 15 mm | In distribution |
| 315-27-03 | In distribution | |
| 308-02-06 | Length 120 mm | In distribution |
| 308-05-17 | Outer Diameter 17.5 mm | In distribution |
| SPI-005670 | In distribution | |
| 315-15-02 | SMALL | In distribution |
| 314-13-25 | In distribution | |
| 301-19-08 | Outer Diameter 8 mm | In distribution |
| SPI-005673 | In distribution | |
| 315-50-11 | In distribution | |
| 313-25-41 | Outer Diameter 41 mm | In distribution |
| 314-13-32 | In distribution | |
| 308-05-31 | Outer Diameter 31.5 mm | In distribution |
| 315-55-02 | SMALL | In distribution |
| 313-25-50 | Outer Diameter 50 mm | In distribution |
| 315-52-62 | In distribution | |
| 313-10-53 | Outer Diameter 53 mm | In distribution |
| 308-16-50 | Size 150 | In distribution |
| 314-02-22 | In distribution | |
| 301-15-08 | Outer Diameter 8 mm | In distribution |
| 311-01-15 | In distribution | |
| 315-54-03 | MEDIUM | In distribution |
| 315-50-12 | In distribution | |
| 308-02-11 | Length 120 mm | In distribution |
| 308-05-23 | Outer Diameter 23.5 mm | In distribution |
| 321-35-20 | In distribution | |
| 301-08-20 | SMALL | In distribution |
| 301-19-11 | Outer Diameter 11 mm | In distribution |
| 300-01-13 | Outer Diameter 13 mm | In distribution |
| 309-15-10 | Outer Diameter 10 mm | In distribution |
| SPI-013385 | In distribution | |
| 308-16-62 | Size 162.5 | In distribution |
| 308-05-30 | Outer Diameter 30.5 mm | In distribution |
| 310-03-47 | beta curvature | In distribution |
| 313-25-38 | Outer Diameter 38 mm | In distribution |
| 314-02-04 | Pegged | In distribution |
| SPI-046719 | In distribution | |
| 311-07-05 | In distribution | |
| 310-22-50 | tall (height) | In distribution |
| 313-10-44 | Outer Diameter 44 mm | In distribution |
| 313-25-53 | Outer Diameter 53 mm | In distribution |
| 331-00-11 | Outer Diameter 11 mm | In distribution |
| 313-10-47 | Outer Diameter 47 mm | In distribution |
| 315-52-04 | In distribution | |
| 301-18-07 | Outer Diameter 7 mm | In distribution |
| 301-09-20 | In distribution | |
| 313-07-07 | In distribution | |
| 315-54-05 | EXTRA LARGE | In distribution |
| 314-13-23 | In distribution | |
| 309-15-09 | Outer Diameter 9 mm | In distribution |
| 310-23-38 | expanded (height) | In distribution |
| 301-19-14 | Outer Diameter 14 mm | In distribution |
| 309-07-09 | In distribution | |
| 301-17-08 | Outer Diameter 8 mm | In distribution |
| 315-52-65 | In distribution | |
| 301-21-50 | Outer Diameter 50 mm | In distribution |
| 308-05-28 | Outer Diameter 28.5 mm | In distribution |
| 331-25-11 | EXTRA SMALL | In distribution |
| 315-60-05 | In distribution | |
| 301-19-10 | Outer Diameter 10 mm | In distribution |
| 314-02-14 | Pegged | In distribution |
| 301-07-20 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| SMR Shoulder | Limacorporate | 182 |
| FX V135 | Fx Shoulder Solutions SAS | 127 |
| Acumed | Acumed LLC | 112 |
| Promos | Smith & Nephew, Inc. | 104 |
| Trabecular Metal® | Zimmer, Inc. | 90 |
| Bigliani/Flatow® | Zimmer, Inc. | 86 |
| Comprehensive® Shoulder System | Biomet Orthopedics | 85 |
| Arthrex® | Arthrex, Inc. | 75 |
| SMR System | Limacorporate | 72 |
| DJO Surgical | Encore Medical, L.P. | 70 |
| Humeris Shoulder | Fx Solutions | 69 |
| Prima | Limacorporate | 67 |
Showing 12 of 241. All products under Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K131298 | 2013-11-26 |
| K061454 | 2006-06-12 |
| K905580 | 1991-03-12 |
| K905577 | 1991-03-12 |
Recalls Naming This Product
34 recalls name this product by its own identifiers, 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 | 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. | 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. | 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 | 2020-08-24 | 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 | 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 |
| Exactech, Inc. | 510(k) number | 2012-06-15 | Class II | Labeling False and Misleading | Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe Compression Screw Kits, Equinoxe Fracture Adapter Tray Screws, and Octane-C Intervertebral fusion devices due to the firm determining that th | 54,877 units for all products in Recall Event | 2013-07-03 |
| Exactech, Inc. | 510(k) number | 2012-06-15 | Class II | Labeling False and Misleading | Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe Compression Screw Kits, Equinoxe Fracture Adapter Tray Screws, and Octane-C Intervertebral fusion devices due to the firm determining that th | 54,877 units for all products in Recall Event | 2013-07-03 |
| Exactech, Inc. | 510(k) number | 2012-06-15 | Class II | Labeling False and Misleading | Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe Compression Screw Kits, Equinoxe Fracture Adapter Tray Screws, and Octane-C Intervertebral fusion devices due to the firm determining that th | 54,877 units for all products in Recall Event | 2013-07-03 |
| Exactech, Inc. | 510(k) number | 2012-06-15 | Class II | Labeling False and Misleading | Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe Compression Screw Kits, Equinoxe Fracture Adapter Tray Screws, and Octane-C Intervertebral fusion devices due to the firm determining that th | 54,877 units for all products in Recall Event | 2013-07-03 |
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.