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ELAN 4

Aesculap AG · Model GP202R · UDI-DI 04046964559549

HBE Prescription

510(k) clearances

21,585

Adverse events (3 deaths)

258

Recalls

140

Facilities

Description

ELAN 4 1-RING NEURO CUTTER+ SOFT D2.0

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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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.