Bit, Drill
Drill BIT Side Cutting (Shannon BUR) Medium/M FOR Stryker TPS Midas REX AND Zimmer Ultrapower
27manufacturers in China registered for this device type
633catalogue 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 | Sterilmed, Inc., United States |
|---|---|
| FDA product code | HTW |
| Device type | Bit, Drill |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Reprocessor, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-06-18 |
| Record revised | 2025-07-09 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2025-08-14 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DEP1801-24-000 | Withdrawn | |
| RIC71173801 | Withdrawn | |
| ARTAR-1406LP | Withdrawn | |
| SYN316.446 | Withdrawn | |
| ZIM00-4836-205-25 | Withdrawn | |
| KOM16-S1702 | Withdrawn | |
| DEP8290-29-070 | Withdrawn | |
| SYN310.530 | Withdrawn | |
| ANSSIL-466-6 | Withdrawn | |
| STR5110-104-10 | Withdrawn | |
| ZIM47-256-01-23 | Withdrawn | |
| SYN323.062 | Withdrawn | |
| SMI71170111 | Withdrawn | |
| RIC21-0444 | Withdrawn | |
| RIC71173362 | Withdrawn | |
| ORTMXM-072-13 | Withdrawn | |
| ARTAR-1406.5 | Withdrawn | |
| DEP8242-73-000 | Withdrawn | |
| STR5820-103-015 | Withdrawn | |
| STR703703 | Withdrawn | |
| STR5800-5-125 | Withdrawn | |
| SMI21-0446 | Withdrawn | |
| STR5820-103-13 | Withdrawn | |
| STR5805-0-036 | Withdrawn | |
| ZIM1147-29 | Withdrawn | |
| SYN317.872 | Withdrawn | |
| KMEKM48-136 | Withdrawn | |
| ORTHCS-072-20 | Withdrawn | |
| SYN310.35 | Withdrawn | |
| SYN315.28 | Withdrawn | |
| DEP281013553 | Withdrawn | |
| ARTAR-1355D | Withdrawn | |
| RIC71751149 | Withdrawn | |
| OST316-0001 | Withdrawn | |
| MIC8054-012 | Withdrawn | |
| STR703702 | Withdrawn | |
| SYN03.503.112 | Withdrawn | |
| ORTMFT-072-24 | Withdrawn | |
| MEDA-3431 | Withdrawn | |
| SYN357.394 | Withdrawn | |
| ZIM00-2490-075-43 | Withdrawn | |
| DEP8290-32-070 | Withdrawn | |
| STR60-20012 | Withdrawn | |
| ARTAR-1408 | Withdrawn | |
| SYN310.141 | Withdrawn | |
| SYN03.503.246 | Withdrawn | |
| RIC21-0442 | Withdrawn | |
| ARTAR-8943-16 | Withdrawn | |
| STRXFO082001 | Withdrawn | |
| STR60-10322 | Withdrawn | |
| KLS25-449-07 | Withdrawn | |
| TRI13652 | Withdrawn | |
| ARTAR-1910 | Withdrawn | |
| SYN310.45 | Withdrawn | |
| ANSADG-10 | Withdrawn | |
| DEP1801-16-000 | Withdrawn | |
| SYN03.010.062 | Withdrawn | |
| SYN310.19 | Withdrawn | |
| ZIM00-2318-032-00 | Withdrawn | |
| DEP1801-20-000 | Withdrawn | |
| SYN03.010.101 | Withdrawn | |
| SYN324.14 | Withdrawn | |
| SYN310.522 | Withdrawn | |
| SYN310.16 | Withdrawn | |
| ACUMS-DC28 | Withdrawn | |
| ACUMS-DCR20 | Withdrawn | |
| SMI71177134 | Withdrawn | |
| MIC8054-014 | Withdrawn | |
| STR703704 | Withdrawn | |
| ZIM2410-33 | Withdrawn | |
| HANDB2.5 | Withdrawn | |
| WRI40100527 | Withdrawn | |
| RIC21-0438 | Withdrawn | |
| SYN310.632 | Withdrawn | |
| ARTAR-1410 | Withdrawn | |
| ARTAR-1408LP | Withdrawn | |
| SYN310.215 | Withdrawn | |
| SYN315.48 | Withdrawn | |
| SMI71934034 | Withdrawn | |
| SMI71934027 | Withdrawn | |
| DEP8290-33-070S | Withdrawn | |
| BIO509148 | Withdrawn | |
| STR6541-3-524 | Withdrawn | |
| RIC71751148 | Withdrawn | |
| SYN03.226.039 | Withdrawn | |
| SYN310.27 | Withdrawn | |
| KLS25-469-11 | Withdrawn | |
| ZIM4806-145-32 | Withdrawn | |
| ACU80-0100 | Withdrawn | |
| SPI50085-014 | Withdrawn | |
| ARTAR-1250LT | Withdrawn | |
| ACU013498 | Withdrawn | |
| DEP1801-16 | Withdrawn | |
| RIC11-7067 | Withdrawn | |
| KLS25-449-05 | Withdrawn | |
| ZIM00-2318-027-00 | Withdrawn | |
| MIC8054-017 | Withdrawn | |
| RIC71631121 | Withdrawn | |
| DEP14629 | Withdrawn | |
| KOMKM166-310-21 | Withdrawn | |
| DEP8290-31-120 | Withdrawn | |
| DEP8207-55-004 | Withdrawn | |
| WLO01-7148 | Withdrawn | |
| STR6838-7-673 | Withdrawn | |
| KLS25-452-00 | Withdrawn | |
| SYN310.20 | Withdrawn | |
| ARTAR-1409 | Withdrawn | |
| ACUAT2M-1813 | Withdrawn | |
| SYN310.430 | Withdrawn | |
| STR6541-4-518 | Withdrawn | |
| SYN310.15 | Withdrawn | |
| SYN315.920 | Withdrawn | |
| STR1320-3042 | Withdrawn | |
| STR4200-355-27 | Withdrawn | |
| SYN310.38 | Withdrawn | |
| SYN324.12 | Withdrawn | |
| SYN310.36 | Withdrawn | |
| ZIM1146-20 | Withdrawn | |
| STR5085-2-032 | Withdrawn | |
| SYN03.112.003 | Withdrawn | |
| ARTAR-1923D | Withdrawn | |
| BIO35-463018 | Withdrawn | |
| MED876-455 | Withdrawn | |
| STR5110-104-15 | Withdrawn | |
| ACUHR-D105 | Withdrawn | |
| STR0277082085S2 | Withdrawn | |
| SYN310.11 | Withdrawn | |
| SYN316.314 | Withdrawn | |
| RIC71173501 | Withdrawn | |
| ANSSIL-DS-A | Withdrawn | |
| ARTAR-1406 | Withdrawn | |
| DEP1801-14-000 | Withdrawn | |
| BIO32-467619 | Withdrawn | |
| STR5120-104-15 | Withdrawn | |
| SYN315.44 | Withdrawn | |
| SYN357.403 | Withdrawn | |
| ORTDRV-072-19 | Withdrawn | |
| STR700354 | Withdrawn | |
| SYN317.871 | Withdrawn | |
| ARTAR-8943-30 | Withdrawn | |
| ZIM5120-52-01 | Withdrawn | |
| DEP9399-99-381 | Withdrawn | |
| BIOS-240QD | Withdrawn | |
| ZIM2360-71-47 | Withdrawn | |
| STR702743 | Withdrawn | |
| SYN315.31 | Withdrawn | |
| RIC11-7066 | Withdrawn | |
| SYN310.284 | Withdrawn | |
| SYN388.394 | Withdrawn | |
| SYN03.122.002 | Withdrawn | |
| ORTMFT-072-19 | Withdrawn | |
| STR6543-4-517 | Withdrawn | |
| ZIM1147-27 | Withdrawn | |
| STR700348 | Withdrawn | |
| SMI71362925 | Withdrawn | |
| KLS25-449-16 | Withdrawn | |
| STR60-13512 | Withdrawn | |
| ZIM2255-35-50 | Withdrawn | |
| ZIM00-2490-054-43 | Withdrawn | |
| SYN316.290 | Withdrawn | |
| KOMKM166-310-26 | Withdrawn | |
| SYN511.415 | Withdrawn | |
| SYN03.114.007 | Withdrawn | |
| ACUAT-7032 | Withdrawn | |
| ARTAR-1224CR | Withdrawn | |
| ZIM4806-110-35 | Withdrawn | |
| STR60-20385 | Withdrawn | |
| SYN324.214 | Withdrawn | |
| SYN315.26 | Withdrawn | |
| ZIM2360-205-27 | Withdrawn | |
| OST320-0012 | Withdrawn | |
| ACU014695 | Withdrawn | |
| KMEKM48-137 | Withdrawn | |
| SMI71933346 | Withdrawn | |
| OST220-0005 | Withdrawn | |
| STR700358 | Withdrawn | |
| TRI09683 | Withdrawn | |
| ACU013663 | Withdrawn | |
| ZIM4806-60-11 | Withdrawn | |
| DEP8290-31-070 | Withdrawn | |
| SMI11-0242 | Withdrawn | |
| RIC21-0440 | Withdrawn | |
| STR60-19526 | Withdrawn | |
| SYN317.66 | Withdrawn | |
| DEP1801-18-000 | Withdrawn | |
| MEDA-3231 | Withdrawn | |
| RIC11-0069 | Withdrawn | |
| DEP2141-23-000 | Withdrawn | |
| STR5800-4-125 | Withdrawn | |
| EME310.67.EM | Withdrawn | |
| SYN310.48 | Withdrawn | |
| STR6541-4-525 | Withdrawn | |
| ARTAR-8920D | Withdrawn | |
| KOMKM166-310-25 | Withdrawn | |
| SYN356.98 | Withdrawn | |
| ZIM1147-30 | Withdrawn | |
| STR60-16007 | Withdrawn | |
| OST316-0105 | Withdrawn | |
| ARTAR-1411 | Withdrawn | |
| ZIM4806-100-27 | Withdrawn | |
| ARTAR-1410LP | Withdrawn | |
| RIC21-0443 | Withdrawn | |
| DEP9399-99-315 | Withdrawn | |
| MIC8053-026 | Withdrawn | |
| STR1806-4270 | Withdrawn | |
| MEDA-3434 | Withdrawn | |
| STR700359 | Withdrawn | |
| OST323-1116 | Withdrawn | |
| ZIM4806-110-25 | Withdrawn | |
| SMI71934032 | Withdrawn | |
| DJO1395-1025 | Withdrawn | |
| SMI71134064 | Withdrawn | |
| RIC71170003 | Withdrawn | |
| KOM04-S1701 | Withdrawn | |
| STR60-16535 | Withdrawn | |
| RIC71631110 | Withdrawn | |
| ZIM2360-32 | Withdrawn | |
| DEP2141-13-032 | Withdrawn | |
| MED6956011 | Withdrawn | |
| SYN311.150 | Withdrawn | |
| ARTAR-1530C-25 | Withdrawn | |
| MICK-18 | Withdrawn | |
| STR5120-103-13 | Withdrawn | |
| ZIM00-2318-048-00 | Withdrawn | |
| DEP2903-26-000 | Withdrawn | |
| LIN8787 | Withdrawn | |
| STR700347 | Withdrawn | |
| SYN316.288 | Withdrawn | |
| RIC71173503 | Withdrawn | |
| STR700357 | Withdrawn | |
| STR4200-355-32 | Withdrawn | |
| ARTAR-1409LP | Withdrawn | |
| ORTCSS-072-47 | Withdrawn | |
| SYN357.099 | Withdrawn | |
| ZIM2410-21 | Withdrawn | |
| RIC7136-2925 | Withdrawn | |
| RIC71173504 | Withdrawn | |
| SMI71692810 | Withdrawn | |
| LIN8788 | Withdrawn | |
| ZIM2410-20 | Withdrawn | |
| KOMKM166-00-01 | Withdrawn | |
| ZIM2360-171-27 | Withdrawn | |
| MED7080510 | Withdrawn | |
| ACU013545 | Withdrawn | |
| ORTMFT-072-40 | Withdrawn | |
| SYN315.23 | Withdrawn | |
| ORTMFT-072-27 | Withdrawn | |
| DEP829034070S | Withdrawn | |
| BIO14-400771 | Withdrawn | |
| BIO01-9192 | Withdrawn |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Aptus | Medartis Inc. | 110 |
Showing 12 of 1,958. All products under Bit, Drill
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2008-08-08 | Not classified | Packaging process control | SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of the pouches were not properly sealed on o | 99 | 2011-04-26 |
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.