Ergo
Catalogue number SPI-045039, listed by Exactech, Inc., United States, under Shoulder Prosthesis, Reverse Configuration. 9 manufacturers in China are registered for this product code.
9manufacturers in China registered for this device type
1catalogue number
21510(k) clearances naming this product code
23recalls on this code
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (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 |
|---|---|---|---|---|
| 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 |
| Changzhou Atomic HI-Tech Radiation Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 8 |
Record
| Listed by | Exactech, Inc., United States |
|---|---|
| FDA product code | PHX |
| Device type | Shoulder Prosthesis, Reverse Configuration |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3660 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2022-06-01 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SPI-045039 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arthrex® | Arthrex, Inc. | 297 |
| FX V135 | Fx Shoulder Solutions SAS | 131 |
| Prima TT Glenoid | Limacorporate | 129 |
| Shoulder Innovations Inset Reverse Total Shoulder | Shoulder Innovations, Inc | 124 |
| Equinoxe | Exactech, Inc. | 123 |
| Veritas rTSA | restor3d, inc. | 112 |
| DJO Surgical | Encore Medical, L.P. | 109 |
| R1 Reverse Shoulder System | Catalyst Orthoscience Inc | 100 |
| Tornier Perform™ Humeral System | Tornier Inc. | 96 |
| MSS – Monobloc stem | Medacta International SA | 92 |
| SMR Shoulder | Limacorporate | 90 |
| Humelock II Cemented Reversible Shoulder | Fx Solutions | 83 |
Showing 12 of 232. All products under Shoulder Prosthesis, Reverse Configuration
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K260583 | 2026-04-14 |
| K243448 | 2025-08-01 |
| K233482 | 2024-07-18 |
| K223833 | 2023-09-14 |
| K193098 | 2020-02-20 |
| K191561 | 2019-08-20 |
| K182536 | 2018-10-12 |
| K180632 | 2018-07-25 |
| K162325 | 2017-03-06 |
| K162726 | 2017-02-01 |
| K150458 | 2015-05-14 |
| K131575 | 2013-07-03 |
| K121067 | 2012-12-06 |
| K110708 | 2011-04-01 |
| K102951 | 2010-11-04 |
| K101909 | 2010-08-02 |
| K093275 | 2010-05-27 |
| K092900 | 2010-01-07 |
| K082702 | 2008-10-10 |
| K073688 | 2008-02-29 |
| K063569 | 2007-02-23 |
Recalls
23 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 | |
| 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 |
| 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 |
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.