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Drills, Burrs, Trephines & Accessories (Simple, Powered)
FDA product code HBE · Class 2 · Neurology
6,769
Registered devices
21,585
Adverse events
258
Recalls
65
510(k) clearances
Devices with this code
Midas Rex MR8 — MEDTRONIC POWERED SURGICAL SOLUTIONSMidas Rex MR8 — MEDTRONIC PS MEDICAL, INC.ELAN 4 — Aesculap AGNA — Synthes GmbHZethon — ZETHON LIMITEDZyphr — STRYKER CORPORATIONMidas Rex MR8 — MEDTRONIC POWERED SURGICAL SOLUTIONSBur PM2-70 80K Diamond coarse Ø3.0 sterile — Bien-Air Surgery SAMidas Rex MR8 — MEDTRONIC POWERED SURGICAL SOLUTIONSAESCULAP — Aesculap AGNA — Anspach Effort, TheNA — Synthes GmbHMIDAS REX MR8 — MEDTRONIC POWERED SURGICAL SOLUTIONS"2.4MM" FRACTURE SYSTEM — BIOMET MICROFIXATION, INCMidas Rex — MEDTRONIC POWERED SURGICAL SOLUTIONSZethon — ZETHON LIMITEDENT MR8 — MEDTRONIC POWERED SURGICAL SOLUTIONSPHASOR — PHASOR HEALTH LLCZethon — ZETHON LIMITEDMIDAS REX MR8 — MEDTRONIC POWERED SURGICAL SOLUTIONSMidas Rex MR8 — MEDTRONIC POWERED SURGICAL SOLUTIONSNA — Synthes GmbHNA — STRYKER CORPORATIONELAN 4 — Aesculap AG
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-30 | SURGIFY MEDICAL OY | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). |
| 2026-04-30 | SURGIFY MEDICAL OY | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). |
| 2026-04-30 | SURGIFY MEDICAL OY | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). |
| 2026-04-30 | SURGIFY MEDICAL OY | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). |
| 2026-04-30 | SURGIFY MEDICAL OY | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). |
| 2026-04-30 | SURGIFY MEDICAL OY | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). |
| 2026-04-30 | SURGIFY MEDICAL OY | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). |
| 2026-04-30 | SURGIFY MEDICAL OY | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). |
| 2026-04-30 | SURGIFY MEDICAL OY | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). |
| 2026-04-30 | SURGIFY MEDICAL OY | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). |
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