Swanson
19 catalogue numbers from 486003N, listed by Wright Medical Technology, Inc., United States, under Prosthesis, Elbow, Hemi-, Radial, Polymer. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
19catalogue numbers in this listing
5recalls on this code
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Wright Medical Technology, Inc., United States |
|---|---|
| FDA product code | KWI |
| Device type | Prosthesis, Elbow, Hemi-, Radial, Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3170 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2015-10-01 |
| Record revised | 2022-05-17 (version 6) |
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 |
| Distribution end date | 2018-05-03 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 486003N | Size: 3 | In distribution |
| 4860003 | Size: 3 | In distribution |
| 4860025 | Size: 2.5 | In distribution |
| 4840002 | Size: 2 | In distribution |
| 48401XL | Size: 1, Extra Large | In distribution |
| 49401XL | Extra Large | In distribution |
| 4840001 | Size: 1 | In distribution |
| 4840025 | Size: 2.5 | In distribution |
| 48403XL | Size: 3XL | In distribution |
| 4840003 | Size: 3 | In distribution |
| 486001N | Size: 1 | In distribution |
| 4860001 | Size: 1 | In distribution |
| 4860002 | Size: 2 | In distribution |
| 4840015 | Size: 1.5 | In distribution |
| 48402XL | Size: 2, Extra Large | In distribution |
| 4860015 | Size: 1.5 | In distribution |
| 4861003 | Size: 3 | Withdrawn |
| 4861015 | Size: 1.5 | Withdrawn |
| 4861025 | Size: 2.5 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Acumed | Acumed LLC | 175 |
| Align | Skeletal Dynamics L.L.C. | 97 |
| Prosthesis, Elbow, Hemi-, Radial, Polymer | Synthes (U.S.A.) LP | 78 |
| Evolve | Wright Medical Technology, Inc. | 75 |
| Rhead | Stryker GmbH | 53 |
| L2L™ | Zimmer, Inc. | 48 |
| Prosthesis, Elbow, Hemi-, Radial, Polymer | Synthes Gmbh | 43 |
| Explor | Biomet Orthopedics | 32 |
| Avenger | IN2BONES USA, LLC | 32 |
| BioPoly® Radial Head Implant | Biopoly, LLC | 30 |
| Seitz Solution Radial Head | Kapp Surgical Instrument, Inc. | 27 |
| Integra® | Ascension Orthopedics, Inc. | 23 |
Showing 12 of 28. All products under Prosthesis, Elbow, Hemi-, Radial, Polymer
Recalls
5 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 |
|---|---|---|---|---|---|
| 2022-08-03 | Class II | Under Investigation by firm | The outer label does not match the device inside the package. The affected lot of EVOLVE Proline Stem 7.5mm +2 contains a size 9.5mm +4 stem, while the affected lot of EVOLVE Proline Stem 9.5mm +4 contains a size 7.5mm +2 stem. | 16 units | |
| 2022-08-03 | Class II | Under Investigation by firm | The outer label does not match the device inside the package. The affected lot of EVOLVE Proline Stem 7.5mm +2 contains a size 9.5mm +4 stem, while the affected lot of EVOLVE Proline Stem 9.5mm +4 contains a size 7.5mm +2 stem. | 32 units | |
| 2020-08-26 | Class II | Process control | Lack of sterility assurance | 16 stems | 2021-04-27 |
| 2019-12-27 | Class II | Process control | Two lots of EVOLVE Modular Radial Head could have the wrong size product in the package. Both the label and laser marking are incorrect on the affected product. | 39 devices | 2021-07-23 |
| 2019-12-27 | Class II | Process control | Two lots of EVOLVE Modular Radial Head could have the wrong size product in the package. Both the label and laser marking are incorrect on the affected product. | 48 devices | 2021-07-23 |
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.