Bit, Drill
96 catalogue numbers from 47-2366-030-18, listed by Zimmer, Inc., United States, under Bit, Drill. 27 manufacturers in China are registered for this product code.
27manufacturers in China registered for this device type
96catalogue numbers in this listing
40recalls on this code
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 | Zimmer, Inc., United States |
|---|---|
| FDA product code | HTW |
| Device type | Bit, Drill |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-12-06 |
| Record revised | 2023-05-03 (version 5) |
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 15 to 305 mm; outer diameter 2.7 to 22 mm; length 10 to 19.5 cm; length 8 in |
| Distribution end date | 2017-12-18 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 47-2366-030-18 | 1.8 mm Diameter | In distribution | |
| 2410-20 | Length 10 cm | In distribution | |
| 2360-270-27 | 2.7 mm Diameter | In distribution | |
| 2318-64-06 | 6.4 mm Diameter | 6 | In distribution |
| 4806-100-27 | 2.7 mm Diameter | In distribution | |
| 75.60.65 | In distribution | ||
| 47-2366-030-24 | 2.4 mm Diameter | In distribution | |
| 2318-32 | 3.2 mm Diameter (.126 Inch) | In distribution | |
| 5785-82 | 8 mm Diameter | In distribution | |
| 4807-195-32 | Length 195 mm | In distribution | |
| 4806-195-45 | Length 195 mm | In distribution | |
| 2360-32 | Outer Diameter 3.2 mm | In distribution | |
| 4806-85-15 | Length 85 mm | In distribution | |
| 4806-100-20 | 2.0 mm Diameter | In distribution | |
| 00-4836-270-25 | 2.5 mm Diameter | In distribution | |
| 00-2366-030-24 | 2.4 mm Diameter | In distribution | |
| 4807-110-25 | 3-Fluted, 2.5 mm Diameter | In distribution | |
| 4807-230-32 | Length 230 mm | In distribution | |
| 4805-130-32 | Length 130 mm | In distribution | |
| 2410-25 | 2.5 mm Diameter | In distribution | |
| 4805-45-11 | Length 45 mm | In distribution | |
| 00-8790-007-03 | 3.2 mm Diameter | In distribution | |
| 4807-145-45 | 3-Fluted, 4.5 mm Diameter | In distribution | |
| 5187 | Outer Diameter 20.00 mm | In distribution | |
| 2318-40-06 | 4.0 mm Diameter | 6 | In distribution |
| 4806-60-11 | 1.1 mm Diameter | In distribution | |
| 4805-95-25 | 2.5 mm Diameter | In distribution | |
| 4807-230-25 | 3-Fluted, 2.5 mm Diameter | In distribution | |
| 2410-32 | Length 14.5 cm | In distribution | |
| 2360-76-27 | Outer Diameter 2.7 mm | In distribution | |
| 5789-42 | 6.3 mm Diameter | In distribution | |
| 00-8790-007-02 | 3.2 mm Diameter | In distribution | |
| 2360-155-18 | 1.8 mm Diameter | In distribution | |
| 2318-40 | 4.0 mm Diameter | In distribution | |
| 2318-64 | 6.4 mm Diameter | In distribution | |
| 4806-305-32 | 3.2 mm Diameter | In distribution | |
| 2318-48 | 4.8 mm Diameter | In distribution | |
| 2410-93 | 2.5 mm Diameter | In distribution | |
| 2360-205-27 | 2.7 mm Diameter | In distribution | |
| 4806-195-32 | 3.2 mm Diameter | In distribution | |
| 2410-94 | 3.2 mm Diameter | In distribution | |
| 2360-175-20 | 2.0 mm Diameter | In distribution | |
| 5907 | Outer Diameter 4.50 mm | In distribution | |
| 2360-240-20 | 2.0 mm Diameter | In distribution | |
| 4806-195-35 | 3.5 mm Diameter | In distribution | |
| 4805-85-27 | 2.7 mm Diameter | In distribution | |
| 5906 | Outer Diameter 4.50 mm | In distribution | |
| 5178 | Outer Diameter 14.00 mm | In distribution | |
| 2360-225-37 | 3.7 mm Diameter | In distribution | |
| 1150-04 | 1.5 mm Diameter | In distribution | |
| 4806-145-32 | 3.2 mm Diameter | In distribution | |
| 2410-36 | Length 19.5 cm | In distribution | |
| 4805-130-45 | Length 130 mm | In distribution | |
| 5791-71 | 3.2 mm Diameter, Size Blue | In distribution | |
| 00-4836-205-25 | 2.5 mm Diameter | In distribution | |
| 2360-171-27 | Outer Diameter 2.7 mm | In distribution | |
| 4807-145-32 | 3-Fluted, 3.2 mm Diameter | In distribution | |
| 00-2366-030-18 | 1.8 mm Diameter | In distribution | |
| 2360-76-47 | Outer Diameter 4.7 mm | In distribution | |
| 4806-145-45 | Length 145 mm | In distribution | |
| 5179 | Outer Diameter 16.00 mm | In distribution | |
| 2360-71-47 | Outer Diameter 4.7 mm | In distribution | |
| 5188 | Outer Diameter 22.00 mm | In distribution | |
| 4805-95-35 | 3.5 mm Diameter | In distribution | |
| 4805-70-15 | 1.5 mm Diameter | In distribution | |
| 2318-48-06 | 4.8 mm Diameter | 6 | In distribution |
| 4806-110-35 | Length 110 mm | In distribution | |
| 5905 | Length 35.50 mm | In distribution | |
| 5120-67 | 12.7 mm Diameter | In distribution | |
| 4806-305-25 | 2.5 mm Diameter | In distribution | |
| 4806-121-24 | 2.4 mm Diameter | In distribution | |
| 4806-110-25 | 2.5 mm Diameter | In distribution | |
| 4805-85-20 | Length 85 mm | In distribution | |
| 4807-195-45 | 3-Fluted, 4.5 mm Diameter | In distribution | |
| 5184 | Outer Diameter 8.00 mm | In distribution | |
| 5177 | Outer Diameter 12.00 mm | In distribution | |
| 4807-180-25 | Length 180 mm | In distribution | |
| 5120-52-01 | 6.4 mm Diameter | In distribution | |
| 5180 | Outer Diameter 18.00 mm | In distribution | |
| 75.11.01-05 | In distribution | ||
| 2410-92 | Length 216 mm | In distribution | |
| 1291-04 | Length 8 in | In distribution | |
| 4806-125-20 | Length 125 mm | In distribution | |
| 2360-315-37 | 3.7 mm Diameter | In distribution | |
| 1150-03 | 2.3 mm Diameter | In distribution | |
| 9310-10-111 | 4.5 mm Diameter | Withdrawn | |
| 9310-10-110 | 4.5 mm Diameter | Withdrawn | |
| 9366-00-041 | 3.2mm/35mm | Withdrawn | |
| 9310-10-131 | Length 35 mm | Withdrawn | |
| 9366-00-061 | 3.5 mm X 16.5 mm Hex Bit | Withdrawn | |
| 6611-03-01 | Length 15 mm | Withdrawn | |
| 9366-00-042 | 3.2mm/50mm | Withdrawn | |
| 9366-00-043 | 4.5mm/35mm | Withdrawn | |
| 00-8790-007-04 | Length 45 mm | Withdrawn | |
| 9310-10-130 | 3.2 mm Diameter | Withdrawn | |
| 9366-00-044 | 4.5mm/50mm | Withdrawn |
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
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 | Closed |
|---|---|---|---|---|
| 2019-04-08 | Class II | Under Investigation by firm | An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | 2020-05-11 |
| 2019-04-08 | Class II | Under Investigation by firm | An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | 2020-05-11 |
| 2019-04-08 | Class II | Under Investigation by firm | An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | 2020-05-11 |
| 2019-04-08 | Class II | Under Investigation by firm | An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | 2020-05-11 |
| 2019-04-08 | Class II | Under Investigation by firm | An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | 2020-05-11 |
| 2019-04-08 | Class II | Under Investigation by firm | An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | 2020-05-11 |
| 2019-04-08 | Class II | Under Investigation by firm | An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | 2020-05-11 |
| 2019-04-08 | Class II | Under Investigation by firm | An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | 2020-05-11 |
| 2019-04-08 | Class II | Under Investigation by firm | An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | 2020-05-11 |
| 2019-04-08 | Class II | Under Investigation by firm | An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | 2020-05-11 |
| 2019-04-08 | Class II | Under Investigation by firm | An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | 2020-05-11 |
| 2019-04-08 | Class II | Under Investigation by firm | An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | 2020-05-11 |
| 2019-04-08 | Class II | Under Investigation by firm | An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | 2020-05-11 |
| 2019-04-08 | Class II | Under Investigation by firm | An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | 2020-05-11 |
| 2019-04-08 | Class II | Under Investigation by firm | An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | 2020-05-11 |
| 2019-04-08 | Class II | Under Investigation by firm | An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | 2020-05-11 |
| 2019-04-08 | Class II | Under Investigation by firm | An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | 2020-05-11 |
| 2019-04-08 | Class II | Under Investigation by firm | An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | 2020-05-11 |
| 2019-04-08 | Class II | Under Investigation by firm | An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | 2020-05-11 |
| 2019-04-08 | Class II | Under Investigation by firm | An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | 2020-05-11 |
| 2019-04-08 | Class II | Under Investigation by firm | An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | 2020-05-11 |
| 2019-04-08 | Class II | Under Investigation by firm | An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | 2020-05-11 |
| 2019-04-08 | Class II | Under Investigation by firm | An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | 2020-05-11 |
| 2019-04-08 | Class II | Under Investigation by firm | An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | 2020-05-11 |
| 2019-04-08 | Class II | Under Investigation by firm | An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | 2020-05-11 |
| 2019-04-08 | Class II | Under Investigation by firm | An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | 2020-05-11 |
| 2019-04-08 | Class II | Under Investigation by firm | An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | 2020-05-11 |
| 2019-04-08 | Class II | Under Investigation by firm | An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | 2020-05-11 |
| 2019-04-08 | Class II | Under Investigation by firm | An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | 2020-05-11 |
| 2019-04-08 | Class II | Under Investigation by firm | An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | 2020-05-11 |
| 2019-04-08 | Class II | Under Investigation by firm | An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | 2020-05-11 |
| 2019-04-08 | Class II | Under Investigation by firm | An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | 2020-05-11 |
| 2019-04-08 | Class II | Under Investigation by firm | An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | 2020-05-11 |
| 2019-04-08 | Class II | Under Investigation by firm | An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | 2020-05-11 |
| 2019-04-08 | Class II | Under Investigation by firm | An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | 2020-05-11 |
| 2019-04-08 | Class II | Under Investigation by firm | An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | 2020-05-11 |
| 2019-04-08 | Class II | Under Investigation by firm | An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | 2020-05-11 |
| 2019-04-08 | Class II | Under Investigation by firm | An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | 2020-05-11 |
| 2019-04-08 | Class II | Under Investigation by firm | An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | 2020-05-11 |
| 2019-04-08 | Class II | Under Investigation by firm | An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | 2020-05-11 |
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.