FDAFDA · Food and drugs·Recall number Z-2556-2026
Surgify Halo, 3.0 mm, Short, Model/Catalog Number: 30.070.NVG.U2; drills, burrs, trephines & accessories (simple, powered)
Published July 1, 2026 · Recall initiated: April 30, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- SURGIFY MEDICAL OY
- Distributor
- US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.
- Lot
- UDI: 06429811532205; All lots until the IFU update has been implemented
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Finland
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