T2, Pangea
AlphaLink Pilot Drill
23manufacturers in China registered for this device type
1catalogue number
3510(k) clearances naming this product code
8recalls 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 | Stryker GmbH, Switzerland |
|---|---|
| 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, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-09-25 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Length 330 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 543533S | Length 330.0 mm | In distribution |
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 |
|---|---|
| K961970 | 1996-07-26 |
| K943589 | 1994-12-15 |
| K942956 | 1994-09-23 |
Recalls
5 of these are Class II. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2017-02-28 | Class II | Use error | Stryker Instruments issued a notice of correction for an update to cleaning practices for the Stryker SmartLife Large Aseptic Housings following complaints of deterioration to the housing and the top and bottom housing separating at the wel | 302 | 2023-01-23 |
| 2016-08-17 | Class II | Packaging | Stryker Instruments is voluntarily recalling the Sagittal Blade 18.0X.97X90MM due to the potential for a sterile barrier breach in the product’s packaging. | 225 | 2017-03-29 |
| 2015-03-25 | Class III | Software design | The Stryker Universal Battery Charger is not transmitting usage data to the Stryker Cloud as designed. The firm is initiating a software correction to address the issue. | 223 chargers | 2015-07-08 |
| 2015-01-07 | Class II | Under Investigation by firm | Stryker is recalling System 6 Aseptic Housing, due to a failed Continuous Bond Line Test from a housing without a continual weld. Customers are instructed to return recalled product to Stryker. | 399 | 2016-03-09 |
| 2014-10-08 | Class II | Process control | The SmartLife Aseptic Housings are being recalled in that the top section of the housing may separate from the bottom section due to insufficient welding. | 3,138 in total | 2016-05-31 |
| 2014-10-08 | Class II | Process control | The SmartLife Aseptic Housings are being recalled in that the top section of the housing may separate from the bottom section due to insufficient welding. | 3,138 in total | 2016-05-31 |
| 2010-06-02 | Not classified | Device Design | The reason for the field action is that the inner diameter of the Bur Guards may be out of specification. If there is excess material on the inside of the Bur Guard at the location where the guard tapers, it may come into contact with the | 10982 | 2011-04-21 |
| 2009-01-27 | Not classified | Process control | Bur guards were distributed without an expiration date, and if they are used after they have expired it could result in the patient or operating room staff experiencing a burn or laceration. | 70 | 2009-12-17 |
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.