Dyonics, Ultra
MTO Replacemnt Power Cord Ultra Shaver
2manufacturers in China registered for this device type
1catalogue number
8recalls on this code
Who Else Makes It
Concentrated in Shanghai (1), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dongguan Kaiser Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 7 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
Record
| Listed by | Smith & Nephew, Inc., United States |
|---|---|
| FDA product code | HAB |
| Device type | Saw, Powered, And Accessories |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4820 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2015-08-30 |
| Record revised | 2023-09-07 (version 4) |
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 |
|---|---|---|
| 7209071 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Saw, Powered, And Accessories | Smith & Nephew, Inc. | 179 |
| Dyonics | Smith & Nephew, Inc. | 49 |
| Zimmer Biomet™ | Zimmer Surgical, Inc. | 43 |
| PowerPro | ConMed Corporation | 29 |
| Saw, Powered, And Accessories | Zimmer Surgical, Inc. | 27 |
| FJ2000 System | Paragon 28 | 26 |
| Dyonics Power | Smith & Nephew, Inc. | 19 |
| Traus | Saeshin Precision Co., Ltd. | 19 |
| Aesculap | Aesculap AG | 17 |
| Hall Microfree | ConMed Corporation | 11 |
| Dyonics / Incisor | Smith & Nephew, Inc. | 7 |
| Apex 3D Total Ankle Replacement System | Paragon 28 | 7 |
Showing 12 of 84. All products under Saw, Powered, And Accessories
Recalls
6 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 |
|---|---|---|---|---|---|
| 2017-02-02 | Class II | Labeling Change Control | The single use devices are provided sterile and do not have an expiration date on the label. | 1410 | 2019-09-20 |
| 2017-02-02 | Class II | Labeling Change Control | The single use devices are provided sterile and do not have an expiration date on the label. | 2496 | 2019-09-20 |
| 2017-02-02 | Class II | Labeling Change Control | The single use devices are provided sterile and do not have an expiration date on the label. | 2646 | 2019-09-20 |
| 2017-02-02 | Class II | Labeling Change Control | The single use devices are provided sterile and do not have an expiration date on the label. | 4500 | 2019-09-20 |
| 2017-02-02 | Class II | Labeling Change Control | The single use devices are provided sterile and do not have an expiration date on the label. | 3462 | 2019-09-20 |
| 2017-02-02 | Class II | Labeling Change Control | The single use devices are provided sterile and do not have an expiration date on the label. | 8748 | 2019-09-20 |
| 2011-05-06 | Not classified | Process control | Product has insufficient weld between the shaft tube and tip, could result in the tip separating from the shaft tube during use. | 744 units | 2012-05-09 |
| 2011-05-06 | Not classified | Process control | Product has insufficient weld between the shaft tube and tip, could result in the tip separating from the shaft tube during use. | 555 units | 2012-05-09 |
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.