R3
Parabolic Acetabular Reamer Dome Size 57MM
23manufacturers in China registered for this device type
147catalogue numbers in this listing
4recalls on this code
Who Else Makes It
Concentrated in Jiangsu (8), Shanghai (6), Guangdong (3). 11 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 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Microport Orthorecon Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 31 |
| Jabil Circuit (Shanghai) Ltd. | Shanghai | Shanghai | Contract manufacturer | 31 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| Dongguan BAO Kang Dian ZI KE JI Limited | Dongguan | Guangdong | Contract manufacturer | 24 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Autocam Medical Devices (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 9 |
| Shaanxi Ansen Medical Technology Development Co., Ltd. | Xi’An | Shaanxi | Contract manufacturer | 7 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
Showing 12 of 23. All 23 manufacturers in China registered for Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Record
| Listed by | Smith & Nephew, Inc., United States |
|---|---|
| FDA product code | HWE |
| Device type | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4820 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-07-25 |
| Record revised | 2023-10-04 (version 7) |
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 |
| Distribution end date | 2022-03-17 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| E0015097-12 | In distribution | |
| E0015097-4 | In distribution | |
| E0016890-2 | In distribution | |
| E0015096-6 | In distribution | |
| E0015562-9 | In distribution | |
| E0016241-5 | In distribution | |
| E0015562-5 | In distribution | |
| 71935350 | In distribution | |
| E0015521-2 | In distribution | |
| E0015097-10 | In distribution | |
| E0015097-9 | In distribution | |
| E0015591-5 | In distribution | |
| 71935339 | In distribution | |
| E0015096-9 | In distribution | |
| E0015521-19 | In distribution | |
| E0016890-7 | In distribution | |
| E0015521-14 | In distribution | |
| E0015522-1 | In distribution | |
| 71935344 | In distribution | |
| E0015522-15 | In distribution | |
| E0015097-1 | In distribution | |
| E0015097-7 | In distribution | |
| E0015096-7 | In distribution | |
| 71935340 | In distribution | |
| E0015522-12 | In distribution | |
| 71935337 | In distribution | |
| 71935346 | In distribution | |
| E0015097-13 | In distribution | |
| E0015591-9 | In distribution | |
| 71935348 | In distribution | |
| E0015521-15 | In distribution | |
| 71935349 | In distribution | |
| 71935331 | In distribution | |
| E0015096-4 | In distribution | |
| E0015522-7 | In distribution | |
| E0015097-5 | In distribution | |
| E0015522-14 | In distribution | |
| E0015096-14 | In distribution | |
| E0015097-11 | In distribution | |
| E0016890-10 | In distribution | |
| E0015096-20 | In distribution | |
| E0016890-20 | In distribution | |
| E0015096-13 | In distribution | |
| E0016890-6 | In distribution | |
| E0015522-6 | In distribution | |
| E0015521-5 | In distribution | |
| E0015522-3 | In distribution | |
| E0015096-12 | In distribution | |
| E0016737-1 | In distribution | |
| 71935332 | In distribution | |
| 71935334 | In distribution | |
| E0016890-16 | In distribution | |
| E0015522-5 | In distribution | |
| E0015303-1 | In distribution | |
| 71935341 | In distribution | |
| E0015521-3 | In distribution | |
| E0015096-19 | In distribution | |
| E0016890-1 | In distribution | |
| E0016890-5 | In distribution | |
| E0015096-18 | In distribution | |
| E0015521-16 | In distribution | |
| E0015521-13 | In distribution | |
| E0015522-2 | In distribution | |
| E0015096-3 | In distribution | |
| E0015521-11 | In distribution | |
| E0016890-19 | In distribution | |
| E0015522-17 | In distribution | |
| 71935329 | In distribution | |
| E0015096-17 | In distribution | |
| 71935336 | In distribution | |
| E0015096-15 | In distribution | |
| E0015097-6 | In distribution | |
| E0015521-9 | In distribution | |
| E0015521-7 | In distribution | |
| E0015521-8 | In distribution | |
| E0015521-17 | In distribution | |
| E0015096-1 | In distribution | |
| E0015096-10 | In distribution | |
| 71935333 | In distribution | |
| E0016890-17 | In distribution | |
| 71935342 | In distribution | |
| E0015522-9 | In distribution | |
| 71935351 | In distribution | |
| E0015522-8 | In distribution | |
| E0015096-2 | In distribution | |
| E0015096-5 | In distribution | |
| E0016890-3 | In distribution | |
| E0015522-16 | In distribution | |
| 71935345 | In distribution | |
| E0015522-18 | In distribution | |
| E0017512-2 | In distribution | |
| E0016890-9 | In distribution | |
| E0015097-2 | In distribution | |
| E0015522-10 | In distribution | |
| E0015303-3 | In distribution | |
| E0016890-11 | In distribution | |
| E0016890-13 | In distribution | |
| 71935330 | In distribution | |
| E0015096-11 | In distribution | |
| E0016890-8 | In distribution | |
| E0015096-8 | In distribution | |
| E0015097-8 | In distribution | |
| E0016890-15 | In distribution | |
| E0015303-2 | In distribution | |
| 71935347 | In distribution | |
| 71935338 | In distribution | |
| 71935328 | In distribution | |
| 71935343 | In distribution | |
| E0016241-9 | In distribution | |
| E0015521-18 | In distribution | |
| E0015096-16 | In distribution | |
| E0015521-12 | In distribution | |
| E0016890-4 | In distribution | |
| E0015521-10 | In distribution | |
| E0015521-4 | In distribution | |
| E0015522-4 | In distribution | |
| E0015521-1 | In distribution | |
| E0016890-14 | In distribution | |
| E0015522-13 | In distribution | |
| E0015097-3 | In distribution | |
| E0015522-11 | In distribution | |
| E0015521-6 | In distribution | |
| E0015097-14 | In distribution | |
| E0016890-12 | In distribution | |
| E0015522-19 | In distribution | |
| E0016890-18 | In distribution | |
| 71935335 | In distribution | |
| E0014787-17 | Withdrawn | |
| E0014787-10 | Withdrawn | |
| E0014787-20 | Withdrawn | |
| E0014787-14 | Withdrawn | |
| E0014787-19 | Withdrawn | |
| E0014787-13 | Withdrawn | |
| E0014787-3 | Withdrawn | |
| E0014787-12 | Withdrawn | |
| E0014787-8 | Withdrawn | |
| E0014787-9 | Withdrawn | |
| E0014787-15 | Withdrawn | |
| E0014787-11 | Withdrawn | |
| E0014787-4 | Withdrawn | |
| E0014787-16 | Withdrawn | |
| E0014787-2 | Withdrawn | |
| E0014787-1 | Withdrawn | |
| E0014787-18 | Withdrawn | |
| E0014787-6 | Withdrawn | |
| E0014787-5 | Withdrawn | |
| E0014787-7 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| EZX | Imedicom Co., Ltd. | 441 |
| Arthrex® | Arthrex, Inc. | 391 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | Stryker GmbH | 284 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 231 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | Synthes Gmbh | 226 |
| Brasseler EZX | Imedicom Co., Ltd. | 187 |
| Conserve® | Microport Orthopedics Inc. | 158 |
| Trigen | Smith & Nephew, Inc. | 139 |
| MicroPort | Microport Orthopedics Inc. | 134 |
| Made-To-Order | Tornier Inc. | 131 |
| Profemur® | Microport Orthopedics Inc. | 129 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | Exactech, Inc. | 129 |
Showing 12 of 1,081. All products under Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
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 |
|---|---|---|---|---|---|
| 2015-09-10 | Class II | Package design/selection | Sterility of device is compromised due to breach in the packaging | 603 units | 2021-06-23 |
| 2015-09-10 | Class II | Package design/selection | Sterility of device is compromised due to breach in the packaging | 1347 units | 2021-06-23 |
| 2015-09-10 | Class II | Package design/selection | Sterility of device is compromised due to breach in the packaging | 1287 units | 2021-06-23 |
| 2015-09-10 | Class II | Package design/selection | Sterility of device is compromised due to breach in the packaging | 1246 units | 2021-06-23 |
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.