Instrument
Tibial Trial Inserter/Extractor Triathlon PKR Instruments
15manufacturers in China registered for this device type
15catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Jiangsu (6), Guangdong (4), Shanghai (2). 10 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 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Microport Orthorecon Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 31 |
| 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 |
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Autocam Medical Devices (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 9 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
Showing 12 of 15. All 15 manufacturers in China registered for Extractor
Record
| Listed by | Howmedica Osteonics Corp, United States |
|---|---|
| FDA product code | HWB |
| Device type | Extractor |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-04-23 |
| Record revised | 2024-09-11 (version 6) |
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 |
|---|---|---|
| I-H2135INS0 | In distribution | |
| I-K0598SH00 | In distribution | |
| 6541-7-806 | In distribution | |
| 6543-6-049 | In distribution | |
| I-K3287HP00 | In distribution | |
| 6541-7-807 | In distribution | |
| 5650-4-805 | In distribution | |
| 6541-4-805 | In distribution | |
| 6541-5-100 | In distribution | |
| 6543-6-850 | In distribution | |
| 8000-8080 | In distribution | |
| I-K1349IMEX | In distribution | |
| 6541-4-804 | In distribution | |
| 6541-4-300 | In distribution | |
| 6541-4-807 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Innomed, Inc. | Innomed, Inc. | 639 |
| Extractor | Depuy Spine, Inc. | 84 |
| Extractor | Synthes Gmbh | 73 |
| Tecomet | Tecomet, Inc. | 68 |
| Shukla Acetabular Cup – S9CUP | Shukla Medical | 64 |
| Shukla Nail S9NAIL | Shukla Medical | 38 |
| Shukla Shoulder S9SHLDR | Shukla Medical | 27 |
| Extractor | Zimmer, Inc. | 27 |
| Shukla Screw S9SCREW | Shukla Medical | 25 |
| Extractor | Exactech, Inc. | 25 |
| Shukla Winquist 3 – MKS1017 | Shukla Medical | 24 |
| Shukla Hip S9HIP | Shukla Medical | 23 |
Showing 12 of 511. All products under Extractor
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2010-03-02 | Not classified | Labeling Change Control | Literature did not include the design change to a smaller cannulation diameter. | 790 unit | 2012-08-06 |
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.