Baby Gorilla®/Gorilla® Plating System
Drill, 3.6 x 160mm, Solid, Measuring, Long, AO
27manufacturers in China registered for this device type
27catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Jiangsu (12), Shanghai (5), Guangdong (4). 12 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| 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 |
| 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 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Autocam Medical Devices (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 9 |
| Aplus (Guangzhou) Medical Technology Company | Guangzhou | Guangdong | Contract manufacturer | 6 |
| Changzhou Wastonortho Medical Appliance Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 5 |
Showing 12 of 27. All 27 manufacturers in China registered for Bit, Drill
Record
| Listed by | Paragon 28, United States |
|---|---|
| FDA product code | HTW |
| Device type | Bit, Drill |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-12-15 |
| Record revised | 2025-04-22 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| P99-100-2510 | In distribution | |
| P99-100-3616 | In distribution | |
| P99-110-4218 | In distribution | |
| P99-100-2816 | In distribution | |
| P99-100-2711 | In distribution | |
| P99-110-3517 | In distribution | |
| P99-100-4212 | In distribution | |
| P99-100-2011 | In distribution | |
| P99-100-2713 | In distribution | |
| P99-100-4214 | In distribution | |
| P80-900-2814 | In distribution | |
| P99-100-3116 | In distribution | |
| P99-105-3080-S | In distribution | |
| P99-100-1310 | In distribution | |
| P99-100-4512 | In distribution | |
| P99-100-2814 | In distribution | |
| P99-100-3511 | In distribution | |
| P99-100-2418 | In distribution | |
| P99-100-2416 | In distribution | |
| P80-910-2814 | In distribution | |
| P99-100-2109 | In distribution | |
| P99-100-2009 | In distribution | |
| P99-100-5212 | In distribution | |
| P99-100-2013 | In distribution | |
| P99-100-3513 | In distribution | |
| P99-100-2414 | In distribution | |
| P99-100-1611 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bit, Drill | Sterilmed, Inc. | 633 |
| Bit, Drill | Synthes Gmbh | 412 |
| Arthrex® | Arthrex, Inc. | 406 |
| Level ONE | KLS-Martin L.P. | 246 |
| Acumed | Acumed LLC | 205 |
| Stryker | Provision | 198 |
| Arthrex | Provision | 186 |
| Tecomet | Tecomet, Inc. | 166 |
| Synthes | Provision | 164 |
| Drill bit | Jeil Medical Corporation | 134 |
| Bit, Drill | AAP Implantate AG | 114 |
| Emerge Medical & Design | Emerge Technologies, Inc. | 110 |
Showing 12 of 1,958. All products under Bit, Drill
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Paragon 28 | UDI-DI | 2022-05-18 | Class II | Under Investigation by firm | Incorrect labeling; There is potential that the drill packaging contains the incorrect part number. | 3 units |
Recalls
1 of these is 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 |
|---|---|---|---|---|---|
| 2021-07-30 | Class II | Process change control | A thin wall condition between the inner cannulation and the flutes of the drill which potentially could cause a fracture through the wall of the drill to the cannulation beneath. | 14 drill bits | 2021-12-15 |
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.