Natural Nail®
Catalogue number 00-2490-005-49, listed by Zimmer, Inc., United States, under Instrument, Compression. 8 manufacturers in China are registered for this product code.
8manufacturers in China registered for this device type
1catalogue number
9recalls on this code
Who Else Makes It
Concentrated in Shanghai (3), Shandong (3), Guangdong (1). 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 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Qingdao Taniking Garment Co., Ltd. | Qingdao | Shandong | Manufacturer | 2 |
Record
| Listed by | Zimmer, Inc., United States |
|---|---|
| FDA product code | HWN |
| Device type | Instrument, Compression |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-11-30 |
| 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 |
|---|---|---|
| 00-2490-005-49 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Instrument, Compression | Synthes Gmbh | 78 |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 42 |
| Invictus | Alphatec Spine, Inc. | 37 |
| Axle Interspinous Fusion System | Xtant Medical Holdings, Inc. | 35 |
| TrabecuLink Femoral and Tibial Cone – Instruments | Waldemar Link GmbH & Co. KG | 32 |
| Made-To-Order | Tornier Inc. | 28 |
| Instrument, Compression | Medtronic Sofamor Danek, Inc. | 20 |
| Tornier Flex | Tornier Inc. | 16 |
| General Instruments | Alphatec Spine, Inc. | 16 |
| Alpine XC Adjustable Fusion System | Highridge Medical, LLC | 14 |
| Coral | Seaspine Orthopedics Corporation | 12 |
| CosmoLock Pedicle Screw System | Kalitec Direct, LLC | 9 |
Showing 12 of 196. All products under Instrument, Compression
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 |
|---|---|---|---|---|---|
| 2010-02-16 | Not classified | Nonconforming Material/Component | The firm determined that the recalled instruments were manufactured using the wrong grade of material. As manufactured, the instruments are more brittle, increasing the potential for fracture. | 2011-10-05 | |
| 2010-02-16 | Not classified | Nonconforming Material/Component | The firm determined that the recalled instruments were manufactured using the wrong grade of material. As manufactured, the instruments are more brittle, increasing the potential for fracture. | 2011-10-05 | |
| 2010-02-16 | Not classified | Nonconforming Material/Component | The firm determined that the recalled instruments were manufactured using the wrong grade of material. As manufactured, the instruments are more brittle, increasing the potential for fracture. | 2011-10-05 | |
| 2010-02-16 | Not classified | Nonconforming Material/Component | The firm determined that the recalled instruments were manufactured using the wrong grade of material. As manufactured, the instruments are more brittle, increasing the potential for fracture. | 2011-10-05 | |
| 2010-02-16 | Not classified | Nonconforming Material/Component | The firm determined that the recalled instruments were manufactured using the wrong grade of material. As manufactured, the instruments are more brittle, increasing the potential for fracture. | 2011-10-05 | |
| 2010-02-16 | Not classified | Nonconforming Material/Component | The firm determined that the recalled instruments were manufactured using the wrong grade of material. As manufactured, the instruments are more brittle, increasing the potential for fracture. | 2011-10-05 | |
| 2010-02-16 | Not classified | Nonconforming Material/Component | The firm determined that the recalled instruments were manufactured using the wrong grade of material. As manufactured, the instruments are more brittle, increasing the potential for fracture. | 217 all products | 2011-10-05 |
| 2010-02-16 | Not classified | Nonconforming Material/Component | The firm determined that the recalled instruments were manufactured using the wrong grade of material. As manufactured, the instruments are more brittle, increasing the potential for fracture. | 2011-10-05 | |
| 2010-02-16 | Not classified | Nonconforming Material/Component | The firm determined that the recalled instruments were manufactured using the wrong grade of material. As manufactured, the instruments are more brittle, increasing the potential for fracture. | 217 all products | 2011-10-05 |
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.