FDA
Food and Drug Administration · Recall Z-2571-2026 · Apr 30, 2026Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
SURGIFY MEDICAL OY
The hazard
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model UDI: 06429811532304Model All lots until the IFU update has been implementedUPC 06429811532304Would you have heard about this one?
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