Surgify Medical Oy: Drills, Burrs, Trephines & Accessories (simple, Powered)

Recalling firm
SURGIFY MEDICAL OY
Product
Surgify Halo, 3.0 mm, Short, Model/Catalog Number: 30.070.NVG.U2; drills, burrs, trephines & accessories (simple, powered)
Reason
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Classification
Class II
Category
medical device recall
Country
United States
Agency
FDA-DEVICES
Recall date
2026-04-30
Status
Open, Classified
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution
US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.

Official recall notice from FDA-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/6b2f7ca1-1e36-4b02-b01f-e51076c66227