Zimmer® Universal Power System
2 catalogue numbers from 89850740000, listed by Zimmer Surgical, Inc., United States, under Saw, Powered, And Accessories. 2 manufacturers in China are registered for this product 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 | Zimmer Surgical, 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, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-05-16 |
| Record revised | 2024-09-19 (version 5) |
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 |
|---|---|---|
| 89850740000 | In distribution | |
| 89850740010 | 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
1 of these is 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 |
|---|---|---|---|---|---|
| 2014-10-06 | Class II | Device Design | Non-injury complaints from Europe identified a malfunction that made it possible for a handpiece to start by itself when the power source is connected. | 828 | 2015-04-15 |
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.