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

Surgify Halo Drill Burr Recall Summary Surgify Medical is recalling its Halo 5.4 mm Long drill burrs (Model 54.125.NVG.U1) used in spinal surgery because the burrs may break during use. The affected devices were distributed nationwide across the United States. Healthcare facilities and surgical centers that use this product should check their inventory.

Recalling firm
SURGIFY MEDICAL OY
Product
Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.U1; 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/c6ad15fe-625b-414a-acff-28ccec054dd5