Zimmer Biomet™
43 catalogue numbers from 89-8509-451-42, listed by Zimmer Surgical, Inc., United States, under Saw, Powered, And Accessories. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
43catalogue numbers in this listing
1recall
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 | 2023-09-18 (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, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 89-8509-451-42 | 2-4 mm | In distribution |
| 89-8509-435-80 | 350 rpm | In distribution |
| 89-8509-425-80 | 250 rpm | In distribution |
| 89-8509-435-50 | 350 rpm | In distribution |
| 89-8509-460-80 | 1/4″ (6.35 mm) | In distribution |
| 89-8509-425-70 | 250 rpm | In distribution |
| 89-8509-435-10 | 350 rpm | In distribution |
| 89-8509-415-80 | 1000 rpm | In distribution |
| 89-8509-451-43 | 0.6-2.2 mm | In distribution |
| 89-8510-420-10 | In distribution | |
| 89-8509-450-40 | 500 rpm | In distribution |
| 89-8509-450-30 | 500 rpm | In distribution |
| 89-8509-152-40 | In distribution | |
| 89-8509-450-60 | In distribution | |
| 89-8509-451-41 | 1-4 mm | In distribution |
| 89-8521-470-70 | In distribution | |
| 89-8509-451-20 | In distribution | |
| 89-8509-460-90 | 1/4″ (6.35 mm) | In distribution |
| 89-8509-435-90 | 350 rpm 1/4″ (6.35 mm) | In distribution |
| 89-8509-450-70 | 500 rpm | In distribution |
| 89-8510-420-20 | In distribution | |
| 89-8509-410-20 | 1000 rpm | In distribution |
| 89-8509-450-80 | 500 rpm | In distribution |
| 89-8509-425-50 | 250 rpm | In distribution |
| 89-8521-470-80 | In distribution | |
| 89-8509-425-30 | 250 rpm | In distribution |
| 89-8509-435-70 | 350 rpm | In distribution |
| 89-8509-410-85 | 1000 rpm 5/32″ (4.0 mm) | In distribution |
| 89-8509-451-46 | 2-4 mm | In distribution |
| 89-8509-435-30 | 350 rpm | In distribution |
| 89-8509-425-90 | 250 rpm 1/4″ (6.35 mm) | In distribution |
| 89-8509-410-90 | 1000 rpm 1/4″ (6.35 mm) | In distribution |
| 89-8509-425-40 | 250 rpm | In distribution |
| 89-8509-435-65 | 350 rpm | In distribution |
| 89-8509-425-10 | 250 rpm | In distribution |
| 89-8509-450-65 | 500 rpm | In distribution |
| 89-8509-415-40 | 1000 rpm | In distribution |
| 89-8509-410-80 | 1000 rpm 1/4″ (6.35 mm) | In distribution |
| 89-8509-435-40 | 350 rpm | In distribution |
| 89-8509-425-65 | 250 rpm | In distribution |
| 89-8509-450-50 | 500 rpm | In distribution |
| 89-8509-450-90 | 500 rpm 1/4″ (6.35 mm) | In distribution |
| 89-8509-450-10 | 500 rpm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Saw, Powered, And Accessories | Smith & Nephew, Inc. | 179 |
| Dyonics | Smith & Nephew, Inc. | 49 |
| 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 |
| Hall® Titan™ | ConMed Corporation | 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.