Provisional Shell
12 catalogue numbers from 00-7040-064-00, listed by Zimmer Trabecular Metal Technology, Inc., United States, under Probe. 12 manufacturers in China are registered for this product code.
12manufacturers in China registered for this device type
12catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Shanghai (4), Jiangsu (4), Shandong (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| Shanghai KiNETIC Medical Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Suzhou Microport Orthorecon Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 31 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Hangzhou Haizhu MIM Products Co., Ltd. | Hangzhou | Zhejiang | Exporter | 28 |
| Suzhou Endophix Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 17 |
| Hangzhou Ruihao Medical Technology Ltd | Hangzhou | Zhejiang | Contract manufacturer | 12 |
| Changzhou Xietong Industries Co., Ltd. | Changzhou | Jiangsu | Exporter | 11 |
Record
| Listed by | Zimmer Trabecular Metal Technology, Inc., United States |
|---|---|
| FDA product code | HXB |
| Device type | Probe |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-06-14 |
| Record revised | 2026-07-09 (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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00-7040-064-00 | Default | In distribution |
| 00-7040-052-00 | Default | In distribution |
| 00-7040-062-00 | Default | In distribution |
| 00-7040-066-00 | Default | In distribution |
| 00-7040-060-00 | Default | In distribution |
| 00-7040-048-00 | Default | In distribution |
| 00-7040-050-00 | Default | In distribution |
| 00-7040-070-00 | Default | In distribution |
| 00-7040-056-00 | Default | In distribution |
| 00-7040-054-00 | Default | In distribution |
| 00-7040-068-00 | Default | In distribution |
| 00-7040-058-00 | Default | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 219 |
| Probe | Depuy Spine, Inc. | 190 |
| Probe | Zimmer Trabecular Metal Technology, Inc. | 154 |
| Sklar® | Sklar Corporation | 136 |
| General Instruments | Alphatec Spine, Inc. | 112 |
| Life Instruments | Life Instrument Corp. | 107 |
| Tecomet | Tecomet, Inc. | 97 |
| Tetris ST | Signus Medizintechnik Gmbh | 65 |
| Invictus | Alphatec Spine, Inc. | 64 |
| Medtronic Resuable Instruments | Medtronic Sofamor Danek, Inc. | 56 |
| Probe | Synthes Gmbh | 47 |
| Tasmin R | Signus Medizintechnik Gmbh | 47 |
Showing 12 of 330. All products under Probe
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 |
|---|---|---|---|---|---|
| 2014-12-02 | Class II | Device Design | During cleaning, two separate units of the NexGen Tibial Base plates did not fit with the Tibial Base Plate handle. | 8 units | 2015-08-28 |
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.