FDA-Device2026-07-01Class IIPROCESSING DEFECT
Surgify Halo 3.0 mm surgical burr recalled for breakage risk during spinal surgery
Surgify Halo burr recalled for breakage risk during spinal surgery
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.
Hazard
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Who it affects
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-2555-2026More Surgify Medical recalls
- FDA-Device2026-07-01Surgify Halo 5.4 mm burr recalled for breakage risk during spinal surgery
- FDA-Device2026-07-01Surgify Halo 40 mm spinal surgery burr recalled for breakage risk during endoscopic procedures
- FDA-Device2026-07-01Surgify Halo 4.0 mm surgical burr recalled for breakage risk during spinal surgery
- FDA-Device2026-07-01Surgify Halo 5.4 mm burr recalled for breakage risk during spinal surgery
- FDA-Device2026-07-01Surgify Halo 5.4 mm spinal surgery burr recalled for breakage risk
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