Drills, Burrs, Trephines & Accessories (Simple, Powered)
3.0mm Precision Neuro (Match Head) with 15.2mm Diamond Coated Shank
3manufacturers in China registered for this device type
948catalogue numbers in this listing
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 |
| 510(k) | K070876 |
| Record published | 2017-07-12 |
| Record revised | 2022-12-09 (version 7) |
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, serial number |
| Storage | Storage environment temperature -20 to 40 °C; Storage environment atmospheric pressure 50 to 106 KiloPascal; Storage environment humidity 10 to 75 % RH |
| Sizes | Length 0.8 to 141 mm; length 7 to 20 cm |
| Distribution end date | 2022-08-27 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5820012307D | Head Diameter: 0.7 Millimeter | In distribution |
| 5130012040 | Diameter: 4.0 Millimeter | In distribution |
| 5110010085 | Diameter: 8.5 Millimeter | In distribution |
| 5820030030 | Diameter: 3.0 Millimeter | In distribution |
| 5130012070 | Diameter: 7.0 Millimeter | In distribution |
| 5820012340D | Head Diameter: 4.0 Millimeter | In distribution |
| 5220107530 | Length 3.8 mm | In distribution |
| 1605005001 | Diameter: 0.5 Millimeter | In distribution |
| 8420107125 | Diameter: 2.5 Millimeter | In distribution |
| 5820025040 | Diameter: 4.0 Millimeter | In distribution |
| 5110010015 | Diameter: 1.5 Millimeter | In distribution |
| 5407-120-450 | Length 7.0 cm | In distribution |
| 5820012330D | Head Diameter: 3.0 Millimeter | In distribution |
| 5130017070S2 | Length 15.0 mm | In distribution |
| 8470009040 | Diameter: 4.0 Millimeter | In distribution |
| 5120012030 | Diameter: 3.0 Millimeter | In distribution |
| 5407-120-070 | Length 14.0 cm | In distribution |
| 5407-120-052 | Length 9.0 cm | In distribution |
| 5540012330 | Diameter: 3.0 Millimeter | In distribution |
| 8450009050 | Diameter: 5.0 Millimeter | In distribution |
| 5820110050C | Diameter: 5.0 Millimeter | In distribution |
| 5110010030 | Diameter: 3.0 Millimeter | In distribution |
| 5540010075 | Diameter: 7.5 Millimeter | In distribution |
| 5120023095 | Length 10.4 mm | In distribution |
| 5190020047 | Diameter: 4.7 Millimeter | In distribution |
| 5130017050 | Diameter: 5.0 Millimeter | In distribution |
| 5640012030 | Diameter: 3.0 Millimeter | In distribution |
| 5820107025 | Diameter: 2.5 Millimeter | In distribution |
| 5820107020 | Length 3.1 mm | In distribution |
| 5230010060 | Diameter: 6.0 Millimeter | In distribution |
| 5820009060 | Diameter: 6.0 Millimeter | In distribution |
| 5210110012 | Diameter: 1.2 Millimeter | In distribution |
| 5190030060 | Length 8.0 mm | In distribution |
| 5400110114 | Diameter: 1.4 Millimeter | In distribution |
| 5820010040 | Diameter: 4.0 Millimeter | In distribution |
| 5820107430S1 | Diameter: 3.0 Millimeter | In distribution |
| 8450107020 | Diameter: 2.0 Millimeter | In distribution |
| 5190010030 | Diameter: 3.0 Millimeter | In distribution |
| 5540012320 | Diameter: 2.0 Millimeter | In distribution |
| 5130010070 | Diameter: 7.0 Millimeter | In distribution |
| 5130016050 | Diameter: 5.0 Millimeter | In distribution |
| 91-10115 | Length 83.0 mm | In distribution |
| 5820009050 | Diameter: 5.0 Millimeter | In distribution |
| 5540013050 | Diameter: 5.0 Millimeter | In distribution |
| 5540011307 | Diameter: 0.7 Millimeter | In distribution |
| 5407-FA2-00R | Length 16.0 mm | In distribution |
| 5407FA3030SP | Diameter: 3.0 Millimeter | In distribution |
| 5540011025 | Diameter: 2.5 Millimeter | In distribution |
| 5130012230 | Diameter: 3.0 Millimeter | In distribution |
| 5820012340 | Diameter: 4.0 Millimeter | In distribution |
| 8420107015 | Diameter: 1.5 Millimeter | In distribution |
| 5230010250 | Diameter: 5.0 Millimeter | In distribution |
| 5130071223S1 | Diameter: 2.3 Millimeter | In distribution |
| 5120104010 | Diameter: 1.0 Millimeter | In distribution |
| 5820010140 | Diameter: 4.0 Millimeter | In distribution |
| 5160020105 | Length 10.7 mm | In distribution |
| 5120071123 | Length 19.0 mm | In distribution |
| 5120080016 | Length 5.5 mm | In distribution |
| 5130012030 | Diameter: 3.0 Millimeter | In distribution |
| 5820107040 | Length 5.1 mm | In distribution |
| 5210110011 | Diameter: 1.1 Millimeter | In distribution |
| 8420010020 | Diameter: 2.0 Millimeter | In distribution |
| 5190010090 | Diameter: 9.0 Millimeter | In distribution |
| 5160030060 | Diameter: 6.0 Millimeter | In distribution |
| 5820018040 | Diameter: 4.0 Millimeter | In distribution |
| 5120030090 | Diameter: 9.0 Millimeter | In distribution |
| 5820017050 | Diameter: 5.0 Millimeter | In distribution |
| 5120107040 | Length 5.1 mm | In distribution |
| 5407-120-484 | Length 14.0 cm | In distribution |
| 5820041040 | Diameter: 4.0 Millimeter | In distribution |
| 5540009050 | Diameter: 5.0 Millimeter | In distribution |
| 5120106010 | Length 6.0 mm | In distribution |
| 5120071023 | Length 15.9 mm | In distribution |
| 5407-120-492 | Length 20.0 cm | In distribution |
| 5160010060 | Diameter: 6.0 Millimeter | In distribution |
| 5210110010 | Diameter: 1.0 Millimeter | In distribution |
| 5120020975S1 | Diameter: 8.0 Millimeter | In distribution |
| 5130020991 | Length 7.9 mm | In distribution |
| 5540011040 | Diameter: 4.0 Millimeter | In distribution |
| 5110071030 | Length 25.0 mm | In distribution |
| 8450009020 | Diameter: 2.0 Millimeter | In distribution |
| 5407-120-442 | In distribution | |
| 5407-NF2-9CM | In distribution | |
| 5130020047 | Diameter: 4.7 Millimeter | In distribution |
| 5820107130 | Length 3.8 mm | In distribution |
| 5190020991 | Length 7.9 mm | In distribution |
| 5230010230 | Diameter: 3.0 Millimeter | In distribution |
| 5820025030 | Diameter: 3.0 Millimeter | In distribution |
| 5820041030 | Diameter: 3.0 Millimeter | In distribution |
| 5540012060 | Diameter: 6.0 Millimeter | In distribution |
| 1605010023 | Diameter: 2.3 Millimeter | In distribution |
| 5230010050 | Diameter: 5.0 Millimeter | In distribution |
| 8470009020 | Diameter: 2.0 Millimeter | In distribution |
| 5300010716S1 | Diameter: 2.0 Millimeter | In distribution |
| 5540011320 | Diameter: 2.0 Millimeter | In distribution |
| 5320010055 | Diameter: 5.5 Millimeter | In distribution |
| 5120022168 | Diameter: 16.8 Millimeter | In distribution |
| 8470107040D | Diameter: 4.0 Millimeter | In distribution |
| 8470107030 | Diameter: 3.0 Millimeter | In distribution |
| 1605010010 | Diameter: 1.0 Millimeter | In distribution |
| 8470010040 | Diameter: 4.0 Millimeter | In distribution |
| 5820012320 | Diameter: 2.0 Millimeter | In distribution |
| 5820010007 | Diameter: 0.7 Millimeter | In distribution |
| 5820013140 | Diameter: 4.0 Millimeter | In distribution |
| 5820009075 | Diameter: 7.5 Millimeter | In distribution |
| 5820013060 | Diameter: 6.0 Millimeter | In distribution |
| 8450010040 | Diameter: 4.0 Millimeter | In distribution |
| 5407-NFA-9CM | Length 9.0 cm | In distribution |
| 5820020050 | Length 7.0 mm | In distribution |
| 8470013040DX | Diameter: 4.0 Millimeter | In distribution |
| 5220030275 | Diameter: 7.5 Millimeter | In distribution |
| 5820013050 | Diameter: 5.0 Millimeter | In distribution |
| 5120013140 | Diameter: 4.0 Millimeter | In distribution |
| 60-23324 | Length 133.5 mm | In distribution |
| 5120066021 | Diameter: 2.1 Millimeter | In distribution |
| 5820012010 | Diameter: 1.0 Millimeter | In distribution |
| 5820020030 | Diameter: 3.0 Millimeter | In distribution |
| 5120066016 | Diameter: 1.6 Millimeter | In distribution |
| 5120020047 | Length 7.9 mm | In distribution |
| 5407-120-970A | Length 16.0 cm | In distribution |
| 5620030050 | Diameter: 5.0 Millimeter | In distribution |
| 5130010060 | Diameter: 6.0 Millimeter | In distribution |
| 5130123126 | Length 10.4 mm | In distribution |
| 5407-120-950C | Length 13.0 cm | In distribution |
| 5820107017 | Head Diameter: 1.7 Millimeter | In distribution |
| 5210110013 | Diameter: 1.3 Millimeter | In distribution |
| 5820101030 | Diameter: 3.0 Millimeter | In distribution |
| 5820010150 | Diameter: 5.0 Millimeter | In distribution |
| 91-25126 | Diameter: 2.5 Millimeter | In distribution |
| 5120024040 | Diameter: 4.0 Millimeter | In distribution |
| 5130020160 | Diameter: 6.5 Millimeter | In distribution |
| 8420010030 | Diameter: 3.0 Millimeter | In distribution |
| 5120012060 | Diameter: 6.0 Millimeter | In distribution |
| 5820010135 | Diameter: 3.5 Millimeter | In distribution |
| 5540011010 | Diameter: 1.0 Millimeter | In distribution |
| 5820020040 | Length 6.0 mm | In distribution |
| 5820012020D | Head Diameter: 2.0 Millimeter | In distribution |
| 5230010040 | Diameter: 4.0 Millimeter | In distribution |
| 8420107120 | Diameter: 2.0 Millimeter | In distribution |
| 91-10315 | Length 76.0 mm | In distribution |
| 5280107530 | Diameter: 3.0 Millimeter | In distribution |
| 5130023126 | Length 10.4 mm | In distribution |
| 5407-120-470 | Length 12.0 cm | In distribution |
| 1605012007 | Diameter: 0.7 Millimeter | In distribution |
| 5820015030 | Diameter: 3.0 Millimeter | In distribution |
| 8450010030 | Diameter: 3.0 Millimeter | In distribution |
| 5120080030 | Diameter: 3.2 Millimeter | In distribution |
| 5120020060 | Diameter: 6.0 Millimeter | In distribution |
| 5820010230 | Diameter: 3.0 Millimeter | In distribution |
| 8470107030DC | Diameter: 3.0 Millimeter | In distribution |
| 5110010045 | Diameter: 4.5 Millimeter | In distribution |
| 5540009030 | Diameter: 3.0 Millimeter | In distribution |
| 5820070025 | Diameter: 2.5 Millimeter | In distribution |
| 5820012030D | Head Diameter: 3.0 Millimeter | In distribution |
| 5130010050 | Diameter: 5.0 Millimeter | In distribution |
| 5130010100 | Diameter: 10.0 Millimeter | In distribution |
| 5130071123 | Diameter: 2.3 Millimeter | In distribution |
| 5130066021S1 | Diameter: 3.2 Millimeter | In distribution |
| 5130010020 | Diameter: 2.0 Millimeter | In distribution |
| 5130080030 | Diameter: 3.2 Millimeter | In distribution |
| 5130107040 | Length 5.1 mm | In distribution |
| 5820070011 | Length 6.0 mm | In distribution |
| 5130010230 | Diameter: 3.0 Millimeter | In distribution |
| 5220071023 | Diameter: 2.3 Millimeter | In distribution |
| 8450107015 | Diameter: 1.5 Millimeter | In distribution |
| 5120016050 | Diameter: 5.0 Millimeter | In distribution |
| 8470107025 | Diameter: 2.5 Millimeter | In distribution |
| 8420107525 | Diameter: 2.5 Millimeter | In distribution |
| 5120070012 | Diameter: 1.2 Millimeter | In distribution |
| 91-20185 | Diameter: 2.0 Millimeter | In distribution |
| 5160010060S1 | Diameter: 3.0 Millimeter | In distribution |
| 5120020991 | Diameter: 9.1 Millimeter | In distribution |
| 5820013150S2 | Diameter: 5.0 Millimeter | In distribution |
| 5820110330 | Head Diameter: 3.0 Millimeter | In distribution |
| 5220030090S1 | Diameter: 9.0 Millimeter | In distribution |
| 5407FA1015 | Diameter: 1.5 Millimeter | In distribution |
| 5820108035 | Length 8.0 mm | In distribution |
| 5820110060 | Head Diameter: 6.0 Millimeter | In distribution |
| 5120071057 | Length 12.0 mm | In distribution |
| 5230010090 | Diameter: 9.0 Millimeter | In distribution |
| 5230010065 | Diameter: 6.5 Millimeter | In distribution |
| 5110010080 | Diameter: 8.0 Millimeter | In distribution |
| 5540009075 | Diameter: 7.5 Millimeter | In distribution |
| 5130020060S2 | Diameter: 6.0 Millimeter | In distribution |
| 5210110014 | Diameter: 1.4 Millimeter | In distribution |
| 5130013240 | Diameter: 4.0 Millimeter | In distribution |
| 5620030010 | Diameter: 1.0 Millimeter | In distribution |
| 5820013160 | Diameter: 6.0 Millimeter | In distribution |
| 5120020775S1 | Diameter: 7.0 Millimeter | In distribution |
| 5160030090 | Length 11.4 mm | In distribution |
| 5540011060 | Diameter: 6.0 Millimeter | In distribution |
| 5220107030 | Diameter: 3.0 Millimeter | In distribution |
| 5190010050 | Diameter: 5.0 Millimeter | In distribution |
| 5820013145S1 | Diameter: 4.5 Millimeter | In distribution |
| 1605012005 | Diameter: 0.5 Millimeter | In distribution |
| 5820010220 | Diameter: 2.0 Millimeter | In distribution |
| 5110010060 | Diameter: 6.0 Millimeter | In distribution |
| 5220010070 | Diameter: 7.0 Millimeter | In distribution |
| 5110010035 | Diameter: 3.5 Millimeter | In distribution |
| 5820010310 | Diameter: 1.0 Millimeter | In distribution |
| 8470107530 | Diameter: 3.0 Millimeter | In distribution |
| 5540009307 | Diameter: 0.7 Millimeter | In distribution |
| 5620030030 | Diameter: 3.0 Millimeter | In distribution |
| 5820012325 | Diameter: 2.5 Millimeter | In distribution |
| 8470012030DC | Diameter: 3.0 Millimeter | In distribution |
| 5820012030 | Diameter: 3.0 Millimeter | In distribution |
| 5120010010 | Diameter: 1.0 Millimeter | In distribution |
| 5230010030 | Diameter: 3.0 Millimeter | In distribution |
| 5220010230 | Diameter: 3.0 Millimeter | In distribution |
| 5540009090 | Diameter: 9.0 Millimeter | In distribution |
| 5400110111 | Diameter: 1.1 Millimeter | In distribution |
| 5120012010 | Diameter: 1.0 Millimeter | In distribution |
| 8470107015 | Diameter: 1.5 Millimeter | In distribution |
| 5820030040 | Diameter: 4.0 Millimeter | In distribution |
| 5120071058 | Length 16.0 mm | In distribution |
| 5220030560 | Diameter: 6.0 Millimeter | In distribution |
| 5130017040 | Diameter: 4.0 Millimeter | In distribution |
| 5820012035 | Diameter: 3.5 Millimeter | In distribution |
| 5407-120-472 | Length 12.0 cm | In distribution |
| 5407-120-950H | In distribution | |
| 5130107230 | Diameter: 3.0 Millimeter | In distribution |
| 5820009030 | Diameter: 3.0 Millimeter | In distribution |
| 5540009305 | Diameter: 0.5 Millimeter | In distribution |
| 5407-FA3-000 | Length 25.0 mm | In distribution |
| 5407-120-950 | Length 13.0 cm | In distribution |
| 5820110050 | Head Diameter: 5.0 Millimeter | In distribution |
| 5820030060 | Diameter: 6.0 Millimeter | In distribution |
| 5820107530S2 | Diameter: 3.0 Millimeter | In distribution |
| 5820010060 | Diameter: 6.0 Millimeter | In distribution |
| 5130020991S1 | Diameter: 9.0 Millimeter | In distribution |
| 5130013170 | Diameter: 7.0 Millimeter | In distribution |
| 5130010040S4 | Diameter: 4.0 Millimeter | In distribution |
| 8450107030D | Diameter: 3.0 Millimeter | In distribution |
| 8450010020 | Diameter: 2.0 Millimeter | In distribution |
| 5820107530 | Length 3.8 mm | In distribution |
| 5820025050 | Diameter: 5.0 Millimeter | In distribution |
| 5820020040S1 | Diameter: 4.0 Millimeter | In distribution |
| 5130012030S1 | Diameter: 3.0 Millimeter | In distribution |
| 5407-120-480 | Length 14.0 cm | In distribution |
| 5820013140S2 | Diameter: 4.0 Millimeter | In distribution |
| 5230030090 | Diameter: 9.0 Millimeter | In distribution |
| 5130107130 | Length 3.8 mm | In distribution |
| 5820071023SP | Head Diameter: 2.3 Millimeter | In distribution |
| 5190013140 | Diameter: 4.0 Millimeter | In distribution |
| 91-10122 | Length 90.0 mm | In distribution |
| 5120013150 | Diameter: 5.0 Millimeter | In distribution |
| 5130013150 | Diameter: 5.0 Millimeter | In distribution |
| 5130010250 | Diameter: 5.0 Millimeter | In distribution |
| 5120107018 | Length 2.4 mm | In distribution |
| 5120030190 | Diameter: 9.0 Millimeter | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Midas REX MR8 | Medtronic Powered Surgical Solutions | 1,006 |
| 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 |
| Midas Rex MR8 | Medtronic PS Medical | 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 Naming This Product
4 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Stryker Instruments | UDI-DI | 2023-06-28 | Class II | Process control | There is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-030 but package contains a 5820-107-530 device). | 491 devices |
| Stryker Instruments | UDI-DI | 2023-06-28 | Class II | Process control | There is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-430 but package contains a 5820-107-530 device or vice versa). | 464 units |
| Stryker Instruments | UDI-DI | 2023-06-28 | Class II | Process control | There is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-430 but package contains a 5820-107-530 device or vice versa). | 1489 units |
| Stryker Instruments | UDI-DI | 2022-06-24 | Class II | Process change control | There is a potential for the core diameter to be undersized, which may lead to the router breaking. A break can lead to unintended metal fragments in the surgical site, resulting in the potential for surgical intervention or damage to criti | 543 |
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.