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Z-2569-2026Class II

SURGIFY MEDICAL OY

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

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 & CAPA
Reason 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.U1; drills, burrs, trephines & accessories (simple, powered)

Code / lot info

UDI: 06429811532328 ; 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. 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. Open the enforcement explorer →