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POWEREASE™ Instruments

MEDTRONIC SOFAMOR DANEK, INC. · Model 2341422L · UDI-DI 00613994649904

HBEHWEGWF
1
510(k) clearances
22,777
Adverse events (3 deaths)
258
Recalls
140
Facilities

Description

TAPPER 2341422L 4.5MM TC OG CANN L

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.