Magna-FX®
Catalogue number 1142-17, listed by Zimmer, Inc., United States, under Countersink. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
1catalogue number
16recalls on this code
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (2), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Changzhou Xietong Industries Co., Ltd. | Changzhou | Jiangsu | Exporter | 11 |
| Changzhou Centrau Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 9 |
Record
| Listed by | Zimmer, Inc., United States |
|---|---|
| FDA product code | HWW |
| Device type | Countersink |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2017-01-30 |
| 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 |
|---|---|---|
| 1142-17 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vilex Tool | Vilex IN Tennessee, Inc. | 25 |
| Countersink | Synthes Gmbh | 21 |
| Countersink | AAP Implantate AG | 18 |
| Countersink | Merete Gmbh | 16 |
| Medline | Medline Industries, Inc. | 12 |
| OrthoSolutions ‘System26’ Bone Screws | Ortho Solutions Inc | 12 |
| Healix | Nvision Biomedical Technologies, Inc | 10 |
| Leos Cannulated Screw System | Tyber Medical | 10 |
| Cardinal Health | Cardinal Health 200, LLC | 10 |
| Tiger | Trilliant Surgical LLC | 9 |
| Dart-Fire | Wright Medical Technology, Inc. | 9 |
| GEO Bone Screw System | Gramercy Extremity Orthopedics, LLC. | 9 |
Showing 12 of 123. All products under Countersink
Recalls
16 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 | Closed |
|---|---|---|---|---|
| 2019-04-08 | Class II | Under Investigation by firm | An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | 2020-05-11 |
| 2019-04-08 | Class II | Under Investigation by firm | An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | 2020-05-11 |
| 2019-04-08 | Class II | Under Investigation by firm | An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | 2020-05-11 |
| 2019-04-08 | Class II | Under Investigation by firm | An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | 2020-05-11 |
| 2019-04-08 | Class II | Under Investigation by firm | An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | 2020-05-11 |
| 2019-04-08 | Class II | Under Investigation by firm | An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | 2020-05-11 |
| 2019-04-08 | Class II | Under Investigation by firm | An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | 2020-05-11 |
| 2019-04-08 | Class II | Under Investigation by firm | An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | 2020-05-11 |
| 2019-04-08 | Class II | Under Investigation by firm | An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | 2020-05-11 |
| 2019-04-08 | Class II | Under Investigation by firm | An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | 2020-05-11 |
| 2019-04-08 | Class II | Under Investigation by firm | An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | 2020-05-11 |
| 2019-04-08 | Class II | Under Investigation by firm | An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | 2020-05-11 |
| 2019-04-08 | Class II | Under Investigation by firm | An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | 2020-05-11 |
| 2019-04-08 | Class II | Under Investigation by firm | An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | 2020-05-11 |
| 2019-04-08 | Class II | Under Investigation by firm | An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | 2020-05-11 |
| 2019-04-08 | Class II | Under Investigation by firm | An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | 2020-05-11 |
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.