Instrument
Specialty Exeter Flexible Trial Plug
5manufacturers in China registered for this device type
7catalogue numbers in this listing
6recalls on this code
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (1), Zhejiang (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
Record
| Listed by | Howmedica Osteonics Corp, United States |
|---|---|
| FDA product code | JDG |
| Device type | Prosthesis, Hip, Femoral Component, Cemented, Metal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3360 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Manufacturer |
| Record published | 2018-05-03 |
| Record revised | 2021-11-03 (version 5) |
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 |
| Sizes | Length 125 to 150 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0585-9-352 | Offset: 37.5 Millimeter | In distribution |
| I-H19660114 | Diameter: 14.0 Millimeter | In distribution |
| I-H19660116 | Diameter: 16.0 Millimeter | In distribution |
| 0585-9-443 | Offset: 44.0 Millimeter | In distribution |
| 0585-3-371 | Size: 1 | In distribution |
| I-H19660108 | Diameter: 8.0 Millimeter | In distribution |
| 0585-9-562 | Offset: 56.0 Millimeter | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| R3 | Smith & Nephew, Inc. | 554 |
| Emperion | Smith & Nephew, Inc. | 262 |
| Reflection | Smith & Nephew, Inc. | 253 |
| Spii Model Lubinus | Waldemar Link GmbH & Co. KG | 174 |
| Polar | Smith & Nephew, Inc. | 132 |
| Anthology | Smith & Nephew, Inc. | 129 |
| Echelon | Smith & Nephew, Inc. | 122 |
| Synergy | Smith & Nephew, Inc. | 102 |
| Prosthesis, Hip, Femoral Component, Cemented, Metal | Smith & Nephew, Inc. | 93 |
| Trigen | Smith & Nephew, Inc. | 66 |
| Prosthesis Head B | Waldemar Link GmbH & Co. KG | 62 |
| Corin Taper-Fit Total Hip System | Corin Limited | 55 |
Showing 12 of 71. All products under Prosthesis, Hip, Femoral Component, Cemented, Metal
Recalls
4 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 |
|---|---|---|---|---|---|
| 2021-12-30 | Class II | Labeling mix-ups | There is a potential label mix between certain lots of Exeter V40 Cemented Hip (125mm) Stem and Exeter V40 Cemented Hip (150mm) Stem. | 59 devices | 2024-03-14 |
| 2021-12-30 | Class II | Labeling mix-ups | There is a potential label mix between certain lots of Exeter V40 Cemented Hip (125mm) Stem and Exeter V40 Cemented Hip (150mm) Stem. | 58 devices | 2024-03-14 |
| 2021-10-15 | Class II | Under Investigation by firm | There is a potential for the outer white Tyvek lid to debond from the sealed package. | ||
| 2021-10-15 | Class II | Under Investigation by firm | XXX | ||
| 2009-09-04 | Not classified | Process control | Packaging mix up between the Taper V40 Femoral Head and the LFIT V40 Femoral Head. | 7 units | 2013-06-26 |
| 2009-09-04 | Not classified | Process control | Packaging mix up between the Taper V40 Femoral Head and the LFIT V40 Femoral Head. | 10 units | 2013-06-26 |
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.