Comprehensive Instrumentation
34 catalogue numbers from 405882, listed by Biomet Orthopedics, 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
34catalogue numbers in this listing
1510(k) clearance
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 | Biomet Orthopedics, United States |
|---|---|
| FDA product code | PHX |
| Device type | Shoulder Prosthesis, Reverse Configuration |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3660 |
| 510(k) | K193373 |
| Record published | 2020-05-23 |
| Record revised | 2025-05-30 (version 9) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 405882 | In distribution | |
| 405960 | 44 mm STD – 36 mm RET +3 | In distribution |
| 110029305 | 41 mm Ø / | In distribution |
| 405968 | 44 mm +10 mm – 36 mm RET +3 | In distribution |
| 405808 | In distribution | |
| 110027742 | In distribution | |
| 405955 | 44 mm +5 mm – 36 mm STD +3 | In distribution |
| 110028522 | In distribution | |
| 405881 | In distribution | |
| 405806 | In distribution | |
| 110028879 | In distribution | |
| 405965 | 44 mm +5 mm – 36 mm RET +3 | In distribution |
| 405800 | In distribution | |
| 110028922 | In distribution | |
| 405832 | In distribution | |
| 110029302 | 36 mm Ø / | In distribution |
| 405832 | In distribution | |
| 110029304 | 36 mm Ø / +6 mm | In distribution |
| 110025762 | In distribution | |
| 110028880 | In distribution | |
| 110028055 | In distribution | |
| 405884 | In distribution | |
| 110025762 | In distribution | |
| 405902 | In distribution | |
| 110017268 | In distribution | |
| 405890 | In distribution | |
| 110017268 | In distribution | |
| 405806 | In distribution | |
| 405880 | In distribution | |
| 405882 | In distribution | |
| 110028923 | In distribution | |
| 405998 | 44 mm +10 – 41 mm Retentive +3 | In distribution |
| 405881 | In distribution | |
| 405833 | 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 |
|---|---|
| K252404 | 2026-04-15 |
Recalls Naming This Product
23 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 |
|---|---|---|---|---|---|---|---|
| Biomet, Inc. | 510(k) number | 2021-01-15 | Class II | Labeling Change Control | Zimmer Biomet is conducting a lot specific medical device recall for the Comprehensive Reverse Shoulder Central Screw, 25 MM Length. It has been determined through a complaint investigation that a 40 MM length central screw was packaged a | 49 | 2023-03-09 |
| Biomet, Inc. | 510(k) number | 2020-11-25 | Class II | Process control | Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device. | 7428 | 2024-05-08 |
| Biomet, Inc. | 510(k) number | 2020-09-02 | Class II | Packaging process control | Product potentially being packaged without a taper adapter or baseplate. The package should contain one (1) baseplate and one (1) taper adapter, product may be packaged with two (2) baseplates and no (0) adapters or with no (0) baseplates a | 3 units | 2020-12-31 |
| Biomet, Inc. | 510(k) number | 2020-04-17 | Class II | Process control | Potential presence of elevated endotoxin levels that exceed the specification limit | 122 units | 2021-06-25 |
| Biomet, Inc. | 510(k) number | 2020-03-13 | Class II | Under Investigation by firm | There were unknown bioburden levels prior to sterilization, which may affect sterility of the product. | 125 | 2021-07-21 |
| Biomet, Inc. | 510(k) number | 2020-02-25 | Class II | Packaging process control | Package is intended to contain one (1) baseplate and one (1) taper adapter; however, devices may be packaged with two (2) baseplates and no (0) adapters. | 21 units | 2020-08-05 |
| Biomet, Inc. | 510(k) number | 2018-12-21 | Class II | Packaging process control | The product was potentially being packaged without a taper adapter. | 52 | 2020-05-06 |
| Biomet, Inc. | 510(k) number | 2017-02-17 | Class II | Process design | Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components. | 28,253 in total | 2018-01-29 |
| Biomet, Inc. | 510(k) number | 2016-12-20 | Class I | Device Design | Higher than anticipated rate of fracturing due to design. Risk of revision surgery due to fracturing. | 4388 | 2017-08-29 |
| Biomet, Inc. | 510(k) number | 2015-01-07 | Class II | Process control | The taper adaptor is missing from the packaging, which may result in a delay in surgery greater than 30 minutes. | 11- 6 consumed, 5 with distributors | 2015-10-22 |
| Biomet, Inc. | 510(k) number | 2013-05-15 | Class II | Device Design | Biomet has initiated this action following an investigation which identified that the slot on the resection guide is offset in the wrong direction. When the slot on the resection guide is offset in the wrong direction, the Steinman pin that | 17 | 2014-06-09 |
| Biomet, Inc. | 510(k) number | 2011-04-22 | Not classified | Employee error | The firm is initiating this recall following an investigation which identified the rare possibility that certain units of Comprehensive Reverse Shoulder Humeral Trays may contain a locking ring that is incorrectly assembled. | 1,575 units all products | 2013-02-21 |
| Biomet, Inc. | 510(k) number | 2011-04-22 | Not classified | Employee error | The firm is initiating this recall following an investigation which identified the rare possibility that certain units of Comprehensive Reverse Shoulder Humeral Trays may contain a locking ring that is incorrectly assembled. | 1,575 units all products | 2013-02-21 |
| Biomet, Inc. | 510(k) number | 2011-04-22 | Not classified | Employee error | The firm is initiating this recall following an investigation which identified the rare possibility that certain units of Comprehensive Reverse Shoulder Humeral Trays may contain a locking ring that is incorrectly assembled. | 1575 all products | 2013-02-21 |
| Biomet, Inc. | 510(k) number | 2011-04-22 | Not classified | Employee error | The firm is initiating this recall following an investigation which identified the rare possibility that certain units of Comprehensive Reverse Shoulder Humeral Trays may contain a locking ring that is incorrectly assembled. | 1575 units all products | 2013-02-21 |
| Biomet, Inc. | 510(k) number | 2011-04-22 | Not classified | Employee error | The firm is initiating this recall following an investigation which identified the rare possibility that certain units of Comprehensive Reverse Shoulder Humeral Trays may contain a locking ring that is incorrectly assembled. | 1575 all products | 2013-02-21 |
| Biomet, Inc. | 510(k) number | 2011-04-22 | Not classified | Employee error | The firm is initiating this recall following an investigation which identified the rare possibility that certain units of Comprehensive Reverse Shoulder Humeral Trays may contain a locking ring that is incorrectly assembled. | 1575 all products | 2013-02-21 |
| Biomet, Inc. | 510(k) number | 2011-04-22 | Not classified | Employee error | The firm is initiating this recall following an investigation which identified the rare possibility that certain units of Comprehensive Reverse Shoulder Humeral Trays may contain a locking ring that is incorrectly assembled. | 1575 all products | 2013-02-21 |
| Biomet, Inc. | 510(k) number | 2011-04-22 | Not classified | Employee error | The firm is initiating this recall following an investigation which identified the rare possibility that certain units of Comprehensive Reverse Shoulder Humeral Trays may contain a locking ring that is incorrectly assembled. | 1575 all products. | 2013-02-21 |
| Biomet, Inc. | 510(k) number | 2011-04-22 | Not classified | Employee error | The firm is initiating this recall following an investigation which identified the rare possibility that certain units of Comprehensive Reverse Shoulder Humeral Trays may contain a locking ring that is incorrectly assembled. | 1,575 all products | 2013-02-21 |
| Biomet, Inc. | 510(k) number | 2011-04-22 | Not classified | Employee error | The firm is initiating this recall following an investigation which identified the rare possibility that certain units of Comprehensive Reverse Shoulder Humeral Trays may contain a locking ring that is incorrectly assembled. | 1575 all products | 2013-02-21 |
| Biomet, Inc. | 510(k) number | 2010-09-13 | Not classified | Pending | The firm received complaints regarding fracturing of the device. | 45 both products | 2011-07-27 |
| Biomet, Inc. | 510(k) number | 2010-09-13 | Not classified | Pending | The firm received complaints regarding fracturing of the device. | 45 both products | 2011-07-27 |
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.