FDAHealthApril 30, 2026
SURGIFY MEDICAL OY — Surgify Halo, 3.0 mm, Extendable, Model/Catalog Number: 30.000.SEE.U2; drills, burrs, trephines & accessories (simple, powered)
⚠️ Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- April 30, 2026
US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.
What's affected?
- Product
- Surgify Halo, 3.0 mm, Extendable, Model/Catalog Number: 30.000.SEE.U2; drills, burrs, trephines & accessories (simple, powered)
- Brand
- SURGIFY MEDICAL OY
- Lot code
- until
Additional details
UDI: 06429811532229; All lots until the IFU update has been implemented
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 15 units.
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