Instrument
Restoration Modular Inst SYS Distal Stem Impactor / Reaming Post
18manufacturers in China registered for this device type
18catalogue numbers in this listing
7recalls on this code
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (4), Shandong (2). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Showing 12 of 18. All 18 manufacturers in China registered for Impactor
Record
| Listed by | Howmedica Osteonics Corp, United States |
|---|---|
| FDA product code | HWA |
| Device type | Impactor |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-11-13 |
| Record revised | 2026-02-09 (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 |
|---|---|---|
| 6541-4-812 | In distribution | |
| I-K2032FI00 | In distribution | |
| 6541-7-811 | In distribution | |
| 6543-4-600 | In distribution | |
| 7000-5529 | In distribution | |
| I-K3047IM30 | In distribution | |
| 6541-4-813 | In distribution | |
| 7000-5525 | In distribution | |
| 6278-1-300 | In distribution | |
| 6541-4-811 | In distribution | |
| 5650-4-811 | In distribution | |
| 5650-4-812 | In distribution | |
| 6543-6-129 | In distribution | |
| 7004-0100 | In distribution | |
| 7000-5526 | In distribution | |
| I-K0598PI00 | In distribution | |
| 6543-6-128 | In distribution | |
| I-K3506KPIS | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| R3 | Smith & Nephew, Inc. | 153 |
| Conserve® | Microport Orthopedics Inc. | 76 |
| DJO Surgical | Encore Medical, L.P. | 73 |
| Impactor | Synthes Gmbh | 56 |
| Innomed, Inc. | Innomed, Inc. | 53 |
| Impactor | Zimmer, Inc. | 50 |
| Impactor | Zimmer Trabecular Metal Technology, Inc. | 43 |
| iNSitu™ Hip System | Nextstep Arthropedix | 41 |
| Apex Knee System | Omni Life Science, Inc. | 40 |
| DJO Surgical | DJO, LLC | 36 |
| Evolution® | Microport Orthopedics Inc. | 35 |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 35 |
Showing 12 of 825. All products under Impactor
Recalls
3 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 |
|---|---|---|---|---|---|
| 2016-08-18 | Class II | Nonconforming Material/Component | Stryker Orthopaedics has received reports of the thread length protruding past the dome of the acetabular trial or implant for the Trident Universal Impactor/Positioner. | 3,768 units | 2018-08-01 |
| 2013-09-30 | Class II | Device Design | Stryker has received complaints associated with cracks and/or fracture of the Ball Impactor Tip and Rim Impactor Tip Instruments. | 1,024 units | 2016-10-19 |
| 2013-09-30 | Class II | Device Design | Stryker has received complaints associated with cracks and/or fracture of the Ball Impactor Tip and Rim Impactor Tip Instruments. | 1,690 units | 2016-10-19 |
| 2008-07-02 | Not classified | Component design/selection | Stryker Orthopaedics became aware that there is a potential inability to release the Scorpio Series 7000 Tibial Impactor/Extractor from a tibial baseplate during use. | 5126 | 2012-08-17 |
| 2006-04-27 | Not classified | Nonconforming Material/Component | The Lateral Decubitus Alignment Guide either did not assemble to its mating part, the Curved Impaction Handle, or partially engages the handle, but does not fully lock. | 61 units | 2009-10-15 |
| 2005-02-23 | Not classified | Device Design | Insertion/Removal Difficulties: The Baseplate Impactor/Extractor may not assemble/disassemble easily to the baseplate. | 293 total units | 2008-05-30 |
| 2003-04-28 | Not classified | Other | The ball retaining sleeve on the Trident Insert Impactor can possibly disassemble. | 1758 | 2003-11-12 |
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.