Cable-Ready®
Catalogue number 3925-11, listed by Zimmer, Inc., United States, under Cutter, Wire. 10 manufacturers in China are registered for this product code.
10manufacturers in China registered for this device type
1catalogue number
1recall
Who Else Makes It
Concentrated in Shanghai (3), Jiangsu (3), Guangdong (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Aplus (Guangzhou) Medical Technology Company | Guangzhou | Guangdong | Contract manufacturer | 6 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Beijing Fule Science & Technology Development Co., Ltd. | Beijing | Beijing | Manufacturer | 31 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
| Jiangsu Taimedical Technology Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 6 |
Record
| Listed by | Zimmer, Inc., United States |
|---|---|
| FDA product code | HXZ |
| Device type | Cutter, Wire |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-07-27 |
| Record revised | 2023-05-03 (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 |
|---|---|---|
| 3925-11 | 1.8 mm Maximum Cable Diameter | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| gSource | Gsource, LLC. | 56 |
| Ambler Surgical | Ambler Surgical, LLC | 44 |
| Millennium | Avalign Technologies, Inc. | 36 |
| V. Mueller | Steris Corporation | 32 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 31 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 31 |
| Schwert | A. Schweickhardt Gmbh & Co. KG | 29 |
| Orthomed | Ortho-MED, Inc. | 24 |
| Tecomet | Tecomet, Inc. | 24 |
| Cutter, Wire | Synthes Gmbh | 22 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 22 |
| Kmedic | Teleflex Medical LLC | 20 |
Showing 12 of 175. All products under Cutter, Wire
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 |
|---|---|---|---|---|---|
| 2020-11-20 | Class II | Under Investigation by firm | Device has the potential for fracture during use. | 4713 | 2022-05-26 |
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.