Drills, Burrs, Trephines & Accessories (simple, Powered)
Neurology · 21 CFR 882.4310
Recent MDR events
21,585 adverse event reports on file
- MIDAS REX MR8Jul 31, 2026MalfunctionMdt Powered Surgical Solutions1625507-2026-05680
- Midas Rex MR8Jul 31, 2026MalfunctionMdt Powered Surgical Solutions1625507-2026-06042
- Midas Rex MR8Jul 31, 2026MalfunctionMdt Powered Surgical Solutions1625507-2026-06043
- MIDAS REX MR8Jul 31, 2026MalfunctionMdt Powered Surgical Solutions1625507-2026-06044
- MIDAS REX MR8Jul 31, 2026MalfunctionMdt Powered Surgical Solutions1625507-2026-06045
- Midas Rex MR8Jul 31, 2026MalfunctionMdt Powered Surgical Solutions1625507-2026-06047
- Midas Rex MR8Jul 31, 2026MalfunctionMdt Powered Surgical Solutions1625507-2026-06049
- MIDAS REX MR8Jul 31, 2026InjuryMdt Powered Surgical Solutions1625507-2026-06051
- MIDAS REX MR8Jul 31, 2026MalfunctionMdt Powered Surgical Solutions1625507-2026-06050
- MIDAS REX MR8Jul 31, 2026MalfunctionMdt Powered Surgical Solutions1625507-2026-06052
Event type breakdown
Most-reported manufacturers
Recalls
258 recall events for this product code
- SURGIFY MEDICAL OYOpen, ClassifiedJun 24, 2026
Surgify Halo, 3.0 mm, Extendable, Model/Catalog Number: 30.000.SEE.U2; drills, burrs, trephines & accessories (simple, powered)
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Z-2555-2026 · View FDA record ↗ - SURGIFY MEDICAL OYOpen, ClassifiedJun 24, 2026
Surgify Halo, 3.0 mm, Short, Model/Catalog Number: 30.070.NVG.U2; drills, burrs, trephines & accessories (simple, powered)
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Z-2556-2026 · View FDA record ↗ - SURGIFY MEDICAL OYOpen, ClassifiedJun 24, 2026
Surgify Halo, 3.0 mm, Long, Model/Catalog Number: 30.125.NVG.U2; drills, burrs, trephines & accessories (simple, powered)
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Z-2557-2026 · View FDA record ↗ - SURGIFY MEDICAL OYOpen, ClassifiedJun 24, 2026
Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.H1; drills, burrs, trephines & accessories (simple, powered)
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Z-2558-2026 · View FDA record ↗ - SURGIFY MEDICAL OYOpen, ClassifiedJun 24, 2026
Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.U1; drills, burrs, trephines & accessories (simple, powered)
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Z-2559-2026 · View FDA record ↗ - SURGIFY MEDICAL OYOpen, ClassifiedJun 24, 2026
Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.H1; drills, burrs, trephines & accessories (simple, powered)
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Z-2560-2026 · View FDA record ↗ - SURGIFY MEDICAL OYOpen, ClassifiedJun 24, 2026
Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Z-2561-2026 · View FDA record ↗ - SURGIFY MEDICAL OYOpen, ClassifiedJun 24, 2026
Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.125.NVG.H1; drills, burrs, trephines & accessories (simple, powered)
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Z-2562-2026 · View FDA record ↗ - SURGIFY MEDICAL OYOpen, ClassifiedJun 24, 2026
Surgify Halo, 40 mm, Long, Model/Catalog Number: 40.125.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Z-2563-2026 · View FDA record ↗ - SURGIFY MEDICAL OYOpen, ClassifiedJun 24, 2026
Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.H1; drills, burrs, trephines & accessories (simple, powered)
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Z-2564-2026 · View FDA record ↗
Registered firms
377 firms currently registered for this product code
Maillefer Instruments Holding Sarl
BALLAIGUES Vaud, CH
Engineered Medical Systems, Llc
Bartlett, TN, US
Gauthier Biomedical, Inc.
Grafton, WI, US
W&h Dentalwerk Buermoos Gmbh - Site 2
BUERMOOS Salzburg, AT
Stryker Instruments
Portage, MI, US
Warsaw Orthopedic, Inc.
WARSAW, IN, US
Sanmed Medikal Otomotiv Tekstil Ticaret Limited Sirketi
Istanbul, TR
Frueh Verpackungstechnik Ag
Fehraltorf Zurich, CH
Surgify Medical Oy
Espoo Uusimaa, FI
Synthes Gmbh
Zuchwil Solothurn, CH
Medtronic Powered Surgical Solutions
FORT WORTH, TX, US
Stryker Ireland Ltd., Instruments Division
CARRIGTWOHILL, CO.CORK Munster, IE
Medtronic Sofamor Danek Usa, Inc.
Memphis, TN, US
Stryker Puerto Rico, Llc.
ARROYO, PR, US
Straits Orthopaedics (mfg) Sdn Bhd
Bandar Cassia Pulau Pinang, MY
Sterigenics Us Llc
Fort Worth, TX, US
Aesculap Ag
TUTTLINGEN, DONAU Baden-Wurttemberg, DE
Precision Edge Surgical Products Company
Sault Sainte Marie, MI, US
Straits Orthopaedics (mfg) Sdn Bhd
Perai Pulau Pinang, MY
Phasor Health, Llc
Houston, TX, US
Synergy Health Sterilisation Uk Ltd
West Yorkshire Bradford, GB
510(k) clearances
65 clearances for this product code
- Surgify Medical OYMar 26, 2026
K253627 · Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo (54.070.NVG.U1); Surgify Halo (54.125.NVG.U1); Surgify Halo (54.000.SEE.U1); Surgify Halo (40.070.NVG.U1); Surgify Halo (40.125.NVG.U1); Surgify Halo (40.000.SEE.U1); Surgify Halo (30.070.NVG.U2); Surgify Halo (30.125.NVG.U2); Surgify Halo (30.000.SEE.U2)
- Hubly, Inc.Nov 6, 2025
K250815 · Hubly Drill (H100)
- Phasor Health, LLCOct 31, 2025
K252060 · GREEN
- Nakanishi, Inc.Sep 19, 2025
K252662 · UniBur
- Surgify Medical OYJun 4, 2025
K251433 · Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1); Surgify Halo (40.070.NVG.H1); Surgify Halo (40.125.NVG.H1); Surgify Halo (40.000.SEE.H1)
- Surgify Medical OYMar 13, 2025
K250380 · Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1)
- Stryker InstrumentsMar 11, 2025
K250374 · iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision Round, Distal Bend (8431-009-030); iBur 4.0mm Precision Round, Distal Bend (8431-009-040); iBur 2.0mm Diamond Round, Distal Bend (8431-012-020D); iBur 3.0mm Diamond Round, Distal Bend (8431-012-030D); iBur 4.0mm Diamond Round, Distal Bend (8431-012-040D); iBur 3.0mm Coarse Diamond Round, Distal Bend (8431-013-030DC); iBur 4.0mm Coarse Diamond Round, Distal Bend (8431-013-040DC); iBur 5.0mm Coarse Diamond R
- Surgify Medical OYNov 29, 2023
K232684 · Surgify Halo