Instrument, Surgical, Orthopedic, Ac-Powered Motor and Accessory/Attachment
105 catalogue numbers from 00-5851-084-00, listed by Zimmer, Inc., United States, under Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment. 23 manufacturers in China are registered for this product code.
23manufacturers in China registered for this device type
105catalogue numbers in this listing
2510(k) clearances naming this product code
40recalls 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 | Zimmer, 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, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-05-24 |
| Record revised | 2023-10-04 (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, manufacturing date |
| Sizes | Length 10 to 25 cm; length 60 to 460 mm; outer diameter 9 to 19 mm; length 5.9 to 9 in |
| Distribution end date | 2017-06-14 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 00-5851-084-00 | In distribution | ||
| 2410-35 | Length 11 cm | In distribution | |
| 1154-02 | 2.0 mm Diameter | In distribution | |
| 5125-11-21 | 21 mm Diameter | In distribution | |
| 00-5851-073-13 | 13 mm Diameter | In distribution | |
| 00-5851-073-14 | 14 mm Diameter | In distribution | |
| 1155-16 | Diameter, 1.6 mm | 5 | In distribution |
| 00-7942-024-00 | In distribution | ||
| 00-5851-071-19 | 19 mm Diameter | In distribution | |
| 00-5851-071-13 | 13 mm Diameter | In distribution | |
| 00-5851-073-16 | 16 mm Diameter | In distribution | |
| 1154-70 | 3.2 mm Diameter | In distribution | |
| 00-5851-071-16 | Length 75 mm | In distribution | |
| 2410-16 | Length 11 cm | In distribution | |
| 2410-26 | Length 12.5 cm | In distribution | |
| 1155-24 | 5.5 mm Diameter | In distribution | |
| 00-5851-073-15 | 15 mm Diameter | In distribution | |
| 00-5851-071-11 | Length 75 mm | In distribution | |
| 2318-20-06 | 2.0 mm Diameter (.079 Inch) | 6 | In distribution |
| 5125-11-20 | 20 mm Diameter | In distribution | |
| 1142-01-25 | Diameter, 2.5 mm | 5 | In distribution |
| 2318-35 | 3.5 mm Diameter (.138 Inch) | In distribution | |
| 00-5851-013-05 | Size C | In distribution | |
| 00-5851-070-15 | Outer Diameter 15 mm | In distribution | |
| 00-5851-073-12 | 12 mm Diameter | In distribution | |
| 2318-11 | 1.1 mm Diameter (.043 Inch) | In distribution | |
| 182-00-69 | Length 9 in | 6 | In distribution |
| 1155-27 | 4.6 mm Diameter | In distribution | |
| 2410-28 | Length 12.5 cm | In distribution | |
| 00-5851-012-05 | Size B | In distribution | |
| 2410-33 | 3.2 mm Diameter | In distribution | |
| 2410-21 | 2.0 mm Diameter | In distribution | |
| 2360-166-50 | 5.0 mm Hex | In distribution | |
| 2410-11 | 1.1 mm Diameter | In distribution | |
| 00-5851-070-12 | Outer Diameter 12 mm | In distribution | |
| 00-5851-071-12 | 12 mm Diameter | In distribution | |
| 2410-40 | Length 20 cm | In distribution | |
| 00-5851-016-05 | Size F | In distribution | |
| 2318-35-06 | 3.5 mm Diameter (.138 Inch) | 6 | In distribution |
| 00-5851-070-19 | Outer Diameter 19 mm | In distribution | |
| 1154-71 | 2.0 mm Diameter | In distribution | |
| 00-5851-073-17 | 17 mm Diameter | In distribution | |
| 2410-50 | 5.0 mm Diameter | In distribution | |
| 2410-56 | Length 19.5 cm | In distribution | |
| 2318-15-06 | 1.5 mm Diameter (.059 Inch) | 6 | In distribution |
| 1155-14 | 3.8 mm Diameter | In distribution | |
| 2318-25 | 2.5 mm Diameter (.098 Inch) | In distribution | |
| 2318-20 | 2.0 mm Diameter (.079 Inch) | In distribution | |
| 00-5851-014-05 | Size D | In distribution | |
| 5125-11-19 | 19 mm Diameter | In distribution | |
| 00-8790-007-05 | In distribution | ||
| 00-5851-070-17 | Outer Diameter 17 mm | In distribution | |
| 00-5851-071-10 | 10 mm Diameter | In distribution | |
| 00-5851-070-18 | Outer Diameter 18 mm | In distribution | |
| 2410-29 | Length 19.5 cm | In distribution | |
| 2410-15 | Length 85 mm | In distribution | |
| 00-5851-070-11 | Outer Diameter 11 mm | In distribution | |
| 00-5851-070-14 | Outer Diameter 14 mm | In distribution | |
| 6290-00-061 | 1/8 Inch (3.2 mm) Diameter, 3.0 Inch (75 mm) | In distribution | |
| 00-5851-070-09 | Outer Diameter 9 mm | In distribution | |
| 1142-01-17 | Length 22.9 cm | 5 | In distribution |
| 2318-25-06 | 2.5 mm Diameter (.098 Inch) | 6 | In distribution |
| 5125-11-23 | 23 mm Diameter | In distribution | |
| 2410-27 | 2.7 mm Diameter | In distribution | |
| 00-5851-071-15 | 15 mm Diameter | In distribution | |
| 1155-15 | 3.1 mm Diameter | In distribution | |
| 00-5851-070-13 | Outer Diameter 13 mm | In distribution | |
| 1291-04-06 | 6.4 mm (1/4 Inch) Diameter | 6 | In distribution |
| 1152-50 | Diameter,.038 Inch (.97 mm) | 5 | In distribution |
| 00-5851-071-09 | 9 mm Diameter | In distribution | |
| 9801-33 | In distribution | ||
| 00-5851-070-10 | Outer Diameter 10 mm | In distribution | |
| 00-5851-073-19 | 19 mm Diameter | In distribution | |
| 00-5851-073-01 | In distribution | ||
| 2318-27 | 2.7 mm Diameter (.106 Inch) | In distribution | |
| 2318-11-06 | 1.1 mm Diameter (.043 Inch) | 6 | In distribution |
| 5125-11-22 | 22 mm Diameter | In distribution | |
| 00-2410-037-00 | 3.5 mm Diameter | In distribution | |
| 2318-15 | 1.5 mm Diameter (.059 Inch) | In distribution | |
| 00-5851-071-18 | Length 75 mm | In distribution | |
| 2318-32-06 | 3.2 mm Diameter (.126 Inch) | 6 | In distribution |
| 5843-51 | In distribution | ||
| 00-5851-071-14 | 14 mm Diameter | In distribution | |
| 2318-45-06 | 4.5 mm Diameter (.177 Inch) | 6 | In distribution |
| 5843-18 | In distribution | ||
| 2360-165-50 | 5.0 mm Hex Screwdriver | In distribution | |
| 2410-46 | 4.5 mm Diameter | In distribution | |
| 00-5851-070-16 | Outer Diameter 16 mm | In distribution | |
| 2318-27-06 | 2.7 mm Diameter (.106 Inch) | 6 | In distribution |
| 00-5851-071-17 | 17 mm Diameter | In distribution | |
| 00-5851-073-18 | 18 mm Diameter | In distribution | |
| 1181-22 | 2.0 mm Diameter | In distribution | |
| 1155-26 | Diameter, 2.0 mm | 5 | In distribution |
| 2410-45 | 4.5 mm Diameter | In distribution | |
| 00-5851-015-05 | Size E | In distribution | |
| 00-5851-085-00 | In distribution | ||
| 5125-11-24 | 24 mm Diameter | In distribution | |
| 2318-45 | 4.5 mm Diameter (.177 Inch) | In distribution | |
| 1154-01 | 2.4 mm Diameter | In distribution | |
| 00-7942-025-00 | Withdrawn | ||
| 999-53 | Withdrawn | ||
| 9310-10-245 | 4.5 mm | Withdrawn | |
| 00-7942-023-00 | Withdrawn | ||
| 9200-01-008 | Withdrawn | ||
| 9200-01-009 | 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 |
| R3 | Smith & Nephew, Inc. | 147 |
| Trigen | Smith & Nephew, Inc. | 139 |
| MicroPort | Microport Orthopedics Inc. | 134 |
| Made-To-Order | Tornier Inc. | 131 |
| Profemur® | Microport Orthopedics Inc. | 129 |
Showing 12 of 1,081. All products under Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K902332 | 1990-06-25 |
| K895198 | 1989-09-15 |
Recalls
40 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 |
|---|---|---|---|---|---|
| 2017-05-22 | Class II | Process control | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture. | 4 units | 2019-03-29 |
| 2017-05-22 | Class II | Process control | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture. | 240 units | 2019-03-29 |
| 2017-05-22 | Class II | Process control | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture. | 595 units | 2019-03-29 |
| 2017-05-22 | Class II | Process control | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture. | 1558 units | 2019-03-29 |
| 2017-05-22 | Class II | Process control | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture. | 198 units | 2019-03-29 |
| 2017-05-22 | Class II | Process control | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture. | 389 units | 2019-03-29 |
| 2017-05-22 | Class II | Process control | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture. | 171 units | 2019-03-29 |
| 2017-05-22 | Class II | Process control | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture. | 224 units | 2019-03-29 |
| 2017-05-22 | Class II | Process control | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture. | 2,038 units | 2019-03-29 |
| 2017-05-22 | Class II | Process control | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture. | 439 units | 2019-03-29 |
| 2017-05-22 | Class II | Process control | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture. | 21 units | 2019-03-29 |
| 2017-05-22 | Class II | Process control | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture. | 2,240 units | 2019-03-29 |
| 2017-05-22 | Class II | Process control | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture. | 300 units | 2019-03-29 |
| 2017-05-22 | Class II | Process control | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture. | 18 units | 2019-03-29 |
| 2017-05-22 | Class II | Process control | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture. | 705 units | 2019-03-29 |
| 2017-05-22 | Class II | Process control | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture. | 198 units | 2019-03-29 |
| 2017-05-22 | Class II | Process control | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture. | 15 units | 2019-03-29 |
| 2017-05-22 | Class II | Process control | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture. | 182 units | 2019-03-29 |
| 2017-05-22 | Class II | Process control | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture. | 1,550 units | 2019-03-29 |
| 2017-05-22 | Class II | Process control | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture. | 1,091 units | 2019-03-29 |
| 2017-05-22 | Class II | Process control | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture. | 2,585 units | 2019-03-29 |
| 2017-05-22 | Class II | Process control | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture. | 30 units | 2019-03-29 |
| 2017-05-22 | Class II | Process control | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture. | 3,640 units | 2019-03-29 |
| 2017-05-22 | Class II | Process control | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture. | 1055 units | 2019-03-29 |
| 2017-05-22 | Class II | Process control | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture. | 62 units | 2019-03-29 |
| 2017-05-22 | Class II | Process control | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture. | 25 units | 2019-03-29 |
| 2017-05-22 | Class II | Process control | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture. | 1,255 units | 2019-03-29 |
| 2017-05-22 | Class II | Process control | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture. | 10 units | 2019-03-29 |
| 2017-05-22 | Class II | Process control | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture. | 173 units | 2019-03-29 |
| 2017-05-22 | Class II | Process control | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture. | 751 units | 2019-03-29 |
| 2017-05-22 | Class II | Process control | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture. | 27 units | 2019-03-29 |
| 2017-05-22 | Class II | Process control | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture. | 1,250 units | 2019-03-29 |
| 2017-05-22 | Class II | Process control | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture. | 75 units | 2019-03-29 |
| 2017-05-22 | Class II | Process control | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture. | 412 units | 2019-03-29 |
| 2017-05-22 | Class II | Process control | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture. | 155 units | 2019-03-29 |
| 2017-05-22 | Class II | Process control | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture. | 10 units | 2019-03-29 |
| 2017-05-22 | Class II | Process control | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture. | 37 units | 2019-03-29 |
| 2017-05-22 | Class II | Process control | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture. | 4,423 units | 2019-03-29 |
| 2017-05-22 | Class II | Process control | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture. | 173 units | 2019-03-29 |
| 2017-05-22 | Class II | Process control | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture. | 453 units | 2019-03-29 |
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.