⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

SURGIFY MEDICAL OY: Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.H1; drills, burrs, trephines & accessories (simple, powered)

Medical DevicesSource: FDA (device) · Date: 2026-07-01

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
SURGIFY MEDICAL OY
Product
Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.H1; drills, burrs, trephines & accessories (simple, powered)
Reason / hazard
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.
Recall initiated
2026-04-30
Code info
UDI: 06429830116998 ; All lots until the IFU update has been implemented
Product quantity
53 units
Voluntary mandated
Voluntary: Firm initiated
City
Espoo
State
N/A
Country
Finland
Event id
98918
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