EXPert Nail
16MM TI Lateral Entry Femoral Recon NAIL-EX/460MM/RT-STERILE
17manufacturers in China registered for this device type
318catalogue numbers in this listing
4recalls on this code
Who Else Makes It
Concentrated in Jiangsu (7), Shanghai (3), Zhejiang (3). 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 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
Showing 12 of 17. All 17 manufacturers in China registered for Rod, Fixation, Intramedullary And Accessories
Record
| Listed by | Synthes Gmbh, Switzerland |
|---|---|
| FDA product code | HSB |
| Device type | Rod, Fixation, Intramedullary And Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3020 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K033618 |
| Record published | 2015-09-14 |
| Record revised | 2025-02-06 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 04.013.436S | In distribution | |
| 04.003.972S | In distribution | |
| 04.031.977S | In distribution | |
| 04.003.753S | In distribution | |
| 04.008.266S | In distribution | |
| 04.031.940S | In distribution | |
| 04.003.468S | In distribution | |
| 04.003.277S | In distribution | |
| 04.031.936S | In distribution | |
| 04.003.764S | In distribution | |
| 04.003.772S | In distribution | |
| 04.003.957S | In distribution | |
| 04.003.373S | In distribution | |
| 04.003.244S | In distribution | |
| 04.003.661S | In distribution | |
| 04.003.360S | In distribution | |
| 04.013.448S | In distribution | |
| 04.008.316S | In distribution | |
| 04.003.844S | In distribution | |
| 04.003.269S | In distribution | |
| 04.003.656S | In distribution | |
| 04.003.940S | In distribution | |
| 04.013.532S | In distribution | |
| 04.003.556S | In distribution | |
| 04.003.644S | In distribution | |
| 04.031.931S | In distribution | |
| 04.003.465S | In distribution | |
| 04.013.660S | In distribution | |
| 04.031.002S | In distribution | |
| 04.003.744S | In distribution | |
| 04.008.328S | In distribution | |
| 04.031.945S | In distribution | |
| 04.008.210S | In distribution | |
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| 04.003.249S | In distribution | |
| 04.031.935S | In distribution | |
| 04.013.828S | In distribution | |
| 04.013.424S | In distribution | |
| 04.013.052 | In distribution | |
| 04.003.853S | In distribution | |
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| 04.003.368S | In distribution | |
| 04.008.366S | In distribution | |
| 04.003.953S | In distribution | |
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| 04.031.957S | In distribution | |
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| 04.031.953S | In distribution | |
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| 04.003.548S | In distribution | |
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| 04.013.368S | In distribution | |
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| 04.031.956S | In distribution | |
| 04.031.951S | In distribution | |
| 04.003.002 | In distribution | |
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| 04.013.544S | In distribution | |
| 04.013.964S | In distribution | |
| 04.031.976S | In distribution | |
| 04.003.476S | In distribution | |
| 04.003.561S | In distribution | |
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| 04.003.348S | In distribution | |
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| 04.003.453S | In distribution | |
| 04.003.357S | In distribution | |
| 04.003.572S | In distribution | |
| 04.003.856S | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| T2 | Stryker GmbH | 1,373 |
| Autobahn | Globus Medical, Inc. | 1,258 |
| Gamma | Stryker GmbH | 1,120 |
| Summa Orthopaedics Femur Nail System | Jeil Medical Corporation | 742 |
| Arix Femur Nail System | Jeil Medical Corporation | 742 |
| Orthofix | Orthofix SRL | 721 |
| Rod, Fixation, Intramedullary And Accessories | Synthes Gmbh | 715 |
| Trigen | Smith & Nephew, Inc. | 681 |
| Arthrex® | Arthrex, Inc. | 665 |
| Precice® Intramedullary Limb Lengthening System | NuVasive Specialized Orthopedics, Inc. | 596 |
| Apex | Orthoxel Designated Activity Company | 569 |
| Natural Nail® | Zimmer, Inc. | 552 |
Showing 12 of 2,207. All products under Rod, Fixation, Intramedullary And Accessories
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Synthes (USA) Products LLC | 510(k) number | 2024-01-24 | Class II | Process control | Products not sterilized, sterility cannot be confirmed | 5 units | |
| Synthes Gmbh | 510(k) number | 2015-05-27 | Class II | Process control | certain lots of the Titanium Recon Screws (6.5mm ) were found to contain the incorrect insert GP0760-A (Synthes Titanium Buttress Locking Plate System), instead of the correct insert GP0706-E (Synthes Titanium Intramedullary Nails and Compo | 276 | 2015-12-18 |
| Synthes USA (HQ), Inc. | 510(k) number | 2012-11-02 | Class II | Packaging change control | Recall was initiated due to the possibility that the outer pouch was compromised. The product is packaged in two pouches; a sterile, internal pouch within an external pouch. It is the outer, external pouch that may be compromised. | 1,011,783 | 2016-09-27 |
Recalls
3 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 | Quantity | Closed |
|---|---|---|---|---|---|
| 2015-04-09 | Class II | Process control | TFNA nails from certain lots were assembled with a locking mechanism too close to the top of the nail. Potential patient impact: surgical delay. | 8175 | 2016-08-18 |
| 2015-02-24 | Class II | Component design/selection | The guide sleeve has the potential to jam in the Aiming Arms, which may delay disassembly and removal of instruments. | 131 | 2015-09-21 |
| 2014-10-29 | Class II | Employee error | The 10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM (Sterile) was assembled incorrectly. If the non conformance goes undetected, it may impact the locking function post-operatively and compromise the bone reduction an | 6 | 2015-12-18 |
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.