Official recall notice
FDA DeviceClass IINotable
Surgify Halo Recall (Jul 2026)
Product: Surgify Halo, 40 mm, Long, Model/Catalog Number: 40.125.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
- Recall date
- 2026-07-01
- Brand
- SURGIFY MEDICAL OY
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Product description
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Affected products
UDI: 06429811532274; All lots until the IFU update has been implemented