OCI X Straight Handle Driver
Catalogue number 4252-2311, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product 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 | Enztec Limited, New Zealand |
|---|---|
| FDA product code | HWA |
| Device type | Impactor |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-03-17 |
| Record revised | 2026-02-09 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4252-2311 | 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
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 |
|---|---|---|---|---|---|
| 2019-08-16 | Class II | Unknown/Undetermined by firm | The femoral impactors have a higher than normal risk of the arm breaking. During impaction the tip of the arm may fracture and separate from the instrument. This may cause a minor delay in surgery. If not retrieved, it may cause an inflamm | 312 Femoral Impactors | 2023-03-02 |
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.