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STRYKER CORPORATION · Model 5820010170S1 · UDI-DI 07613154186747

HBE Prescription
10
510(k) clearances
21,585
Adverse events (3 deaths)
258
Recalls
140
Facilities

Description

7.0mm Round Fluted Soft Touch, Aggressive

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.