Official recall notice

FDA DeviceClass IINotable

Surgify Halo Recall (Jul 2026)

Product: Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.U1; drills, burrs, trephines & accessories (simple, powered)

Recall date
2026-07-01
FDA class
Class II

Why it was recalled

Hazard

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

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Product description

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Affected products

UDI: 06429811532304 ; All lots until the IFU update has been implemented

Verify with the official notice →
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