FDA-Device2026-07-01Class IIPROCESSING DEFECT
Surgify Halo 3.0 mm burr recalled for breakage risk during spinal surgery
What this means
Surgify Medical's Halo 3.0 mm burr (Model 30.070.NVG.U2) may break during bi-portal endoscopic spinal surgery (BESS). The risk affects all lots distributed in the US until updated instructions are provided.
- If you use this burr in spinal surgery, contact Surgify Medical for updated instructions before using remaining stock.
- Do not use affected burrs until you have received and reviewed the updated 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
N/A
Manufactured in
Otakaari 5 I, N/A, Espoo, N/A, Finland
Products
Surgify Halo, 3.0 mm, Short, Model/Catalog Number: 30.070.NVG.U2; drills, burrs, trephines & accessories (simple, powered)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2556-2026Want us to check the next one for you?
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