Recalling firm
SURGIFY MEDICAL OY
Product type
Device
Status
Ongoing
Report date
2026-07-01
Distribution
US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.
Firm state
N/A
Product quantity
N/A
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPAReason for recall
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Product description
Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.H1; burrs, trephines & accessories (simple, powered)
Code / lot info
UDI: 06429811532120 ; All lots until the IFU update has been implemented
Other recalls SPEQ maps to Risk Management & CAPA
See all Risk Management & CAPA recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.