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HS Matchstick Bur,Ø3.0x150,80K

Bien-Air Surgery SA · Model 361130 L · UDI-DI 17630055507614

HBEHBCNLYERLEQJ Prescription
10
510(k) clearances
22,777
Adverse events (3 deaths)
258
Recalls
140
Facilities

Recalls

DateFirmReason
2026-04-30SURGIFY MEDICAL OYPotential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
2026-04-30SURGIFY MEDICAL OYPotential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
2026-04-30SURGIFY MEDICAL OYPotential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
2026-04-30SURGIFY MEDICAL OYPotential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
2026-04-30SURGIFY MEDICAL OYPotential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
2026-04-30SURGIFY MEDICAL OYPotential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
2026-04-30SURGIFY MEDICAL OYPotential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
2026-04-30SURGIFY MEDICAL OYPotential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
2026-04-30SURGIFY MEDICAL OYPotential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
2026-04-30SURGIFY MEDICAL OYPotential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.