Consumer Alerts Tracker
openFDA Medical device

Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.U1; drills, burrs, trephines & accessories (simple, powered)

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

Official details

Category
Medical device recall
Status
Ongoing
Classification
Class II
Company or vendor
SURGIFY MEDICAL OY
Affected product
US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.
Risk or reason
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Remedy or action
UDI: 06429811532267; All lots until the IFU update has been implemented
Official ID
Z-2561-2026