Reamer
15.5MM Reamer Head-Sterile FOR Reamer/Irrigator/Aspirator
23manufacturers in China registered for this device type
152catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Jiangsu (8), Shanghai (6), Zhejiang (3). 8 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 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Microport Orthorecon Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 31 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Changzhou Master Precision Tool Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 3 |
| 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 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
Showing 12 of 23. All 23 manufacturers in China registered for Reamer
Record
| Listed by | Synthes Gmbh, Switzerland |
|---|---|
| FDA product code | HTO |
| Device type | Reamer |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K013527 |
| Record published | 2016-12-31 |
| Record revised | 2026-05-22 (version 8) |
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 |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2025-07-29 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 03.025.027 | In distribution | ||
| SD03.010.093 | In distribution | ||
| 03.010.093 | In distribution | ||
| 03.045.029S | In distribution | ||
| 352.257S | In distribution | ||
| 352.130 | In distribution | ||
| 03.211.116 | In distribution | ||
| 03.404.035 | In distribution | ||
| 309.250 | In distribution | ||
| 03.211.012 | In distribution | ||
| 03.025.134 | In distribution | ||
| SD03.402.712 | In distribution | ||
| 03.404.020S | In distribution | ||
| 03.233.011S | In distribution | ||
| 03.025.037 | In distribution | ||
| 352.263S | In distribution | ||
| 03.404.019S | In distribution | ||
| 351.97 | In distribution | ||
| 03.211.010 | In distribution | ||
| 309.200 | In distribution | ||
| 03.211.106 | In distribution | ||
| 352.190 | In distribution | ||
| SD352.120 | In distribution | ||
| 03.211.118 | In distribution | ||
| 352.185 | In distribution | ||
| 309.470 | In distribution | ||
| 03.211.008 | In distribution | ||
| 03.211.006 | In distribution | ||
| 03.211.112 | In distribution | ||
| 03.211.122 | In distribution | ||
| 03.404.023S | In distribution | ||
| SD03.045.029 | In distribution | ||
| 03.007.017 | In distribution | ||
| 352.125 | In distribution | ||
| 352.175 | In distribution | ||
| 03.404.018S | In distribution | ||
| 03.025.031 | In distribution | ||
| SD312.005 | In distribution | ||
| 03.045.029 | In distribution | ||
| 03.630.902 | In distribution | ||
| 352.260S | In distribution | ||
| SD03.211.120 | In distribution | ||
| 03.233.010S | In distribution | ||
| 351.43 | In distribution | ||
| SD352.100 | In distribution | ||
| 309.270 | In distribution | ||
| 352.100 | In distribution | ||
| 03.211.114 | In distribution | ||
| 03.211.018 | In distribution | ||
| 352.095 | In distribution | ||
| SD351.92 | In distribution | ||
| SD352.130 | In distribution | ||
| 03.025.135 | In distribution | ||
| 351.707S | In distribution | ||
| 314.742 | In distribution | ||
| 03.025.039 | In distribution | ||
| 352.170 | In distribution | ||
| SD03.211.118 | In distribution | ||
| 351.94 | In distribution | ||
| 03.404.017S | In distribution | ||
| 352.252S | In distribution | ||
| 03.211.022 | In distribution | ||
| 352.115 | In distribution | ||
| 351.95 | In distribution | ||
| 03.211.110 | In distribution | ||
| 351.76 | In distribution | ||
| SD03.010.094 | In distribution | ||
| 309.180 | In distribution | ||
| 352.085 | In distribution | ||
| SD310.973 | In distribution | ||
| 351.718S | 2 | In distribution | |
| 03.025.038 | In distribution | ||
| 351.96 | In distribution | ||
| 351.709S | In distribution | ||
| SD352.115 | In distribution | ||
| 357.403 | In distribution | ||
| 03.045.017 | In distribution | ||
| 352.145 | In distribution | ||
| 352.265S | In distribution | ||
| 324.071 | In distribution | ||
| 352.140 | In distribution | ||
| SD03.211.122 | In distribution | ||
| 03.211.024 | In distribution | ||
| 03.404.024S | In distribution | ||
| SD03.211.116 | In distribution | ||
| 03.404.022S | In distribution | ||
| 352.150 | In distribution | ||
| 309.170 | In distribution | ||
| 03.211.124 | In distribution | ||
| 03.211.014 | In distribution | ||
| 351.16 | In distribution | ||
| 309.280 | In distribution | ||
| 352.160 | In distribution | ||
| 309.150 | In distribution | ||
| 03.607.000 | In distribution | ||
| 351.71 | In distribution | ||
| 351.704S | In distribution | ||
| 352.044 | In distribution | ||
| 309.070 | In distribution | ||
| 338.442 | In distribution | ||
| 309.080 | In distribution | ||
| 03.211.020 | In distribution | ||
| 351.91 | In distribution | ||
| 03.404.027S | In distribution | ||
| 351.15 | In distribution | ||
| SD03.402.711 | In distribution | ||
| 352.040 | In distribution | ||
| 03.211.108 | In distribution | ||
| 03.402.711 | In distribution | ||
| 03.025.030 | In distribution | ||
| 03.207.007 | In distribution | ||
| 352.105 | In distribution | ||
| 352.155 | In distribution | ||
| 309.035 | In distribution | ||
| 352.250S | In distribution | ||
| 351.708S | In distribution | ||
| 03.404.028S | In distribution | ||
| 388.532 | In distribution | ||
| 03.404.029S | In distribution | ||
| 309.480 | In distribution | ||
| 351.80 | In distribution | ||
| 351.71S | In distribution | ||
| 351.92 | In distribution | ||
| 352.120 | In distribution | ||
| 352.135 | In distribution | ||
| 352.229S | In distribution | ||
| SD352.110 | In distribution | ||
| 03.211.016 | In distribution | ||
| 309.670 | In distribution | ||
| 03.025.028 | In distribution | ||
| 03.211.120 | In distribution | ||
| 352.255S | In distribution | ||
| 351.76S | In distribution | ||
| 351.706S | In distribution | ||
| 03.404.001S | In distribution | ||
| 352.180 | In distribution | ||
| 309.068 | In distribution | ||
| SD309.039 | In distribution | ||
| 03.401.074 | In distribution | ||
| 309.065 | In distribution | ||
| 352.262S | In distribution | ||
| 03.404.026S | In distribution | ||
| 03.404.025S | In distribution | ||
| 309.038 | In distribution | ||
| 352.090 | In distribution | ||
| 351.93 | In distribution | ||
| 352.110 | In distribution | ||
| 352.165 | In distribution | ||
| 309.370 | In distribution | ||
| SD309.066 | In distribution | ||
| 309.450 | In distribution | ||
| 351.16J | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Trigen | Smith & Nephew, Inc. | 1,029 |
| Viant Medical, LLC | Viant Medical, LLC | 825 |
| R3 | Smith & Nephew, Inc. | 287 |
| Reamer | Ortho Development Corp. | 259 |
| InSitu Hip System | Nextstep Arthropedix | 181 |
| Apex Knee System | Omni Life Science, Inc. | 162 |
| Reclaim | Depuy (Ireland) | 138 |
| Reamer | Zimmer, Inc. | 135 |
| Endo-Model Knee System – Instruments | Waldemar Link GmbH & Co. KG | 109 |
| DJO Surgical | Encore Medical, L.P. | 108 |
| Arthrex® | Arthrex, Inc. | 105 |
| Arthrex | Provision | 98 |
Showing 12 of 1,224. All products under Reamer
Recalls Naming This Product
19 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 | 144 units | |
| Synthes (USA) Products LLC | 510(k) number | 2020-11-19 | Class II | Use error | RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed | 1297 US 528 OUS | 2022-07-01 |
| Synthes (USA) Products LLC | 510(k) number | 2020-11-19 | Class II | Use error | RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed | 1066 US; 397 OUS | 2022-07-01 |
| Synthes (USA) Products LLC | 510(k) number | 2020-11-19 | Class II | Use error | RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed | 1275 US and 445 OUS | 2022-07-01 |
| Synthes (USA) Products LLC | 510(k) number | 2020-11-19 | Class II | Use error | RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed | 1231US; 422 OUS | 2022-07-01 |
| Synthes (USA) Products LLC | 510(k) number | 2020-11-19 | Class II | Use error | RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed | 1566 US ; 732 OUS | 2022-07-01 |
| Synthes (USA) Products LLC | 510(k) number | 2020-11-19 | Class II | Use error | RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed | 1337 US; 453 OUS | 2022-07-01 |
| Synthes (USA) Products LLC | 510(k) number | 2020-11-19 | Class II | Use error | RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed | 1447 US; 554 OUS | 2022-07-01 |
| Synthes (USA) Products LLC | 510(k) number | 2020-11-19 | Class II | Use error | RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed | 1262 US; 549 OUS | 2022-07-01 |
| Synthes (USA) Products LLC | 510(k) number | 2020-11-19 | Class II | Use error | RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed | 1328 US ; 578 OUS | 2022-07-01 |
| Synthes (USA) Products LLC | 510(k) number | 2020-11-19 | Class II | Use error | RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed | 1142 US; 450 OUS | 2022-07-01 |
| Synthes (USA) Products LLC | 510(k) number | 2020-11-19 | Class II | Use error | RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed | 748 US; 381 OUS | 2022-07-01 |
| Synthes (USA) Products LLC | 510(k) number | 2020-11-19 | Class II | Use error | RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed | 642 US; 325 OUS | 2022-07-01 |
| Synthes (USA) Products LLC | 510(k) number | 2020-11-19 | Class II | Use error | RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed | 651US : 326 OUS | 2022-07-01 |
| Synthes (USA) Products LLC | 510(k) number | 2020-11-19 | Class II | Use error | RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed | 531 US; 317 OUS | 2022-07-01 |
| Synthes (USA) Products LLC | 510(k) number | 2020-11-19 | Class II | Use error | RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed | 572 US; 200 OUS | 2022-07-01 |
| Synthes (USA) Products LLC | 510(k) number | 2020-11-19 | Class II | Use error | RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed | 515 US; 150 OUS | 2022-07-01 |
| Synthes (USA) Products LLC | 510(k) number | 2020-11-19 | Class II | Use error | RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed | 542 US ; 154 OUS | 2022-07-01 |
| Synthes Gmbh | 510(k) number | 2015-05-28 | Class II | Labeling False and Misleading | It was reported that the RIA Drive Shaft, Tube Assembly, and Reamer Head have the potential to break when incorrectly assembled or used improperly. Precautionary statements are being added to the Reamer / Irrigator / Aspirator (RIA) Surgica | 132564 | 2016-08-18 |
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.