Core
Catalogue number 5402007000, listed by Stryker GmbH, Switzerland, under Drills, Burrs, Trephines & Accessories (Simple, Powered). 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
1catalogue number
7510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (1). 2 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 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | HBE |
| Device type | Drills, Burrs, Trephines & Accessories (Simple, Powered) |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4310 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2018-12-11 |
| Record revised | 2022-01-31 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5402007000 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Midas REX MR8 | Medtronic Powered Surgical Solutions | 1,006 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | Stryker GmbH | 948 |
| Elan 4 | Aesculap AG | 529 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | Synthes Gmbh | 514 |
| Zethon | Zethon Ltd | 237 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | Stryker Leibinger Gmbh & Co. KG | 220 |
| Midas Rex® | Medtronic Powered Surgical Solutions | 167 |
| HiCUT Burs | Adeor Medical AG | 90 |
| Phasor | Phasor Health, LLC | 80 |
| Traumaone System | Biomet Microfixation | 62 |
| Midas REX Microsaws | Medtronic Powered Surgical Solutions | 60 |
| Mids REX MR8 | Medtronic Powered Surgical Solutions | 59 |
Showing 12 of 269. All products under Drills, Burrs, Trephines & Accessories (Simple, Powered)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K210377 | 2021-06-30 |
| K191049 | 2019-06-18 |
| K190172 | 2019-06-14 |
| K143399 | 2015-05-08 |
| K143540 | 2015-05-01 |
| K143320 | 2015-04-23 |
| K943541 | 1995-05-18 |
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 |
|---|---|---|---|---|---|
| 2016-11-30 | Class II | Storage | Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion. | 1,257 in total | 2017-06-01 |
| 2016-11-30 | Class II | Storage | Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion. | 1,257 in total | 2017-06-01 |
| 2016-11-30 | Class II | Storage | Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion. | 1,257 in total | 2017-06-01 |
| 2016-11-30 | Class II | Storage | Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion. | 1,257 in total | 2017-06-01 |
| 2016-11-30 | Class II | Storage | Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion. | 1,257 in total | 2017-06-01 |
| 2016-11-30 | Class II | Storage | Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion. | 1,257 in total | 2017-06-01 |
| 2016-11-30 | Class II | Storage | Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion. | 1257 in total | 2017-06-01 |
| 2016-06-24 | Class II | Process design | A variation in flute depth on the routers was observed. The variation in flute depth may cause the routers to be more susceptible to breakages. Risk to Health: Injury to critical soft tissue requiring surgical intervention may occur. | 3,163 | 2017-03-23 |
| 2016-06-16 | Class II | Under Investigation by firm | Stryker Instruments initiated a voluntary recall of specific lots of Round Fluted Burs, due to tarnishing or corrosion which may be present on the recalled burs and could result in a foreign body reaction (inflammation) necessitating surgic | 25 | 2017-06-06 |
| 2016-06-16 | Class II | Under Investigation by firm | Stryker Instruments initiated a voluntary recall of specific lots of Round Fluted Burs, due to tarnishing or corrosion which may be present on the recalled burs and could result in a foreign body reaction (inflammation) necessitating surgic | 25 | 2017-06-06 |
| 2014-05-22 | Class II | Nonconforming Material/Component | There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite” Attachments. | 12 | 2015-05-06 |
| 2014-05-22 | Class II | Nonconforming Material/Component | There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite” Attachments. | 256 | 2015-05-06 |
| 2014-05-22 | Class II | Nonconforming Material/Component | There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite” Attachments. | 84 | 2015-05-06 |
| 2014-05-22 | Class II | Nonconforming Material/Component | There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite” Attachments. | 107 | 2015-05-06 |
| 2014-05-22 | Class II | Nonconforming Material/Component | There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite” Attachments. | 802 | 2015-05-06 |
| 2014-05-22 | Class II | Nonconforming Material/Component | There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite” Attachments. | 285 | 2015-05-06 |
| 2014-05-22 | Class II | Nonconforming Material/Component | There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite” Attachments. | 497 | 2015-05-06 |
| 2014-05-22 | Class II | Nonconforming Material/Component | There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite” Attachments. | 281 | 2015-05-06 |
| 2014-05-22 | Class II | Nonconforming Material/Component | There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite” Attachments. | 609 | 2015-05-06 |
| 2014-05-22 | Class II | Nonconforming Material/Component | There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite” Attachments. | 4 | 2015-05-06 |
| 2014-05-22 | Class II | Nonconforming Material/Component | There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite” Attachments. | 301 | 2015-05-06 |
| 2014-05-22 | Class II | Nonconforming Material/Component | There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite” Attachments. | 27 | 2015-05-06 |
| 2014-05-22 | Class II | Nonconforming Material/Component | There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite” Attachments. | 41 | 2015-05-06 |
| 2014-05-22 | Class II | Nonconforming Material/Component | There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite” Attachments. | 4 | 2015-05-06 |
| 2014-05-22 | Class II | Nonconforming Material/Component | There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite” Attachments. | 15 | 2015-05-06 |
| 2014-05-22 | Class II | Nonconforming Material/Component | There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite” Attachments. | 6481 | 2015-05-06 |
| 2014-05-22 | Class II | Nonconforming Material/Component | There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite” Attachments. | 6 | 2015-05-06 |
| 2014-05-22 | Class II | Nonconforming Material/Component | There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite” Attachments. | 246 | 2015-05-06 |
| 2014-05-22 | Class II | Nonconforming Material/Component | There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite” Attachments. | 99 | 2015-05-06 |
| 2014-05-22 | Class II | Nonconforming Material/Component | There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite” Attachments. | 59 | 2015-05-06 |
| 2014-05-22 | Class II | Nonconforming Material/Component | There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite” Attachments. | 144 | 2015-05-06 |
| 2014-05-22 | Class II | Nonconforming Material/Component | There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite” Attachments. | 188 | 2015-05-06 |
| 2014-05-22 | Class II | Nonconforming Material/Component | There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite” Attachments. | 72 | 2015-05-06 |
| 2014-05-22 | Class II | Nonconforming Material/Component | There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite” Attachments. | 71 | 2015-05-06 |
| 2014-05-22 | Class II | Nonconforming Material/Component | There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite” Attachments. | 1537 | 2015-05-06 |
| 2014-05-22 | Class II | Nonconforming Material/Component | There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite” Attachments. | 1 | 2015-05-06 |
| 2014-05-22 | Class II | Nonconforming Material/Component | There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite” Attachments. | 39 | 2015-05-06 |
| 2014-05-22 | Class II | Nonconforming Material/Component | There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite” Attachments. | 252 | 2015-05-06 |
| 2014-05-22 | Class II | Nonconforming Material/Component | There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite” Attachments. | 916 | 2015-05-06 |
| 2014-05-22 | Class II | Nonconforming Material/Component | There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite” Attachments. | 176 | 2015-05-06 |
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.