FDA-Device2026-07-01Class IIPROCESSING DEFECT
Surgify Halo 3.0 mm surgical burr recalled for breakage risk during spinal surgery
What this means
Surgify Medical's Halo 3.0 mm extendable burr (Model 30.000.SEE.U2) may break during bi-portal endoscopic spinal surgery. The breakage could occur during the procedure. This affects 15 units distributed across several US states.
- If you use this burr in spinal procedures, stop using it until Surgify issues updated instructions.
- Check your inventory for Model 30.000.SEE.U2 (UDI: 06429811532229).
- Contact Surgify Medical for guidance on replacement or corrected instructions.
The agency's original wording
Hazard
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.
Affected count
15 units
Manufactured in
Otakaari 5 I, N/A, Espoo, N/A, Finland
Products
Surgify Halo, 3.0 mm, Extendable, Model/Catalog Number: 30.000.SEE.U2; drills, burrs, trephines & accessories (simple, powered)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2555-2026Want us to check the next one for you?
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