TransFx®
Catalogue number 00-4450-093-00, listed by Zimmer, Inc., United States, under Driver, Surgical, Pin. 12 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Guangdong (5), Zhejiang (4), Shanghai (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| Planet(Shanghai) International Co., Ltd. | Shanghai | Shanghai | Exporter | 93 |
| Planet (Anhui) International Co., Ltd. | Chuzhou | Anhui | Exporter | 80 |
| Ningbo Tianbo First AID Product Co., Ltd. | Ningbo | Zhejiang | Repacker / relabeller | 66 |
| Dongguan City Ruimi Gift Products Co Ltd | Dongguan | Guangdong | Repacker / relabeller | 62 |
| Firstar Healthcare Company Limited (Guangzhou) | Guangzhou | Guangdong | Contract manufacturer | 57 |
| Yiwu Ori-Power Medtech Co., Ltd. | Yiwu | Zhejiang | Contract manufacturer | 46 |
| Guangdong Comfort Medical Products Co., Ltd. | Jiangmen | Guangdong | Repacker / relabeller | 28 |
| Guizhou Zirui Technology Co., Ltd. | Tongzi County, Zunyi | Guizhou | Manufacturer | 4 |
Record
| Listed by | Zimmer, Inc., United States |
|---|---|
| FDA product code | GFC |
| Device type | Driver, Surgical, Pin |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4820 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-07-22 |
| Record revised | 2023-05-03 (version 3) |
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 |
|---|---|---|
| 00-4450-093-00 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Driver, Surgical, Pin | AAP Implantate AG | 18 |
| Orthopediatrics Instrumentation | Orthopediatrics, Corp | 15 |
| PIN Driver | Gebr. Brasseler Gmbh & Co. KG | 13 |
| Driver, Surgical, Pin | Synthes Gmbh | 12 |
| Consensus Knee System/Revision Knee System | Shalby Advanced Technologies, Inc. | 9 |
| PIN Driver/Bone Tamp | Sontec Instruments, Inc. | 8 |
| Komet PIN Driver | Gebr. Brasseler Gmbh & Co. KG | 8 |
| Broken Screw Removal Instruments | Orthopediatrics, Corp | 7 |
| tangis | Nvision Biomedical Technologies, Inc | 6 |
| Tahoe Unicompartmental Knee System | Shalby Advanced Technologies, Inc. | 4 |
| Power Torque Instrumentation | Orthopediatrics, Corp | 4 |
| Pediatric Nailing Platform Femur | Orthopediatrics, Corp | 3 |
Showing 12 of 41. All products under Driver, Surgical, Pin
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 |
|---|---|---|---|---|---|
| 2014-09-09 | Class II | Device Design | The Persona 48mm X 2.5mm Female Screw is being recalled due to potential use of the screw in cortical bone, and corresponding stripping of the 2.5mm Persona Hex Driver. | 16,380 units | 2015-05-05 |
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.