FDA-Device2026-07-01Class IIPROCESSING DEFECT
Surgify Halo 4.0 mm burr recalled for potential breakage during spinal surgery
What this means
Surgify Medical's Halo 4.0 mm burr (Model 40.125.NVG.H1) may break during bi-portal endoscopic spinal surgery (BESS). The breakage could occur while the burr is in use, potentially affecting the procedure.
- If you use or have this burr in your facility, contact Surgify Medical for updated instructions before using any remaining stock.
- Do not use affected burrs until you receive 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
0
Manufactured in
Otakaari 5 I, N/A, Espoo, N/A, Finland
Products
Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.125.NVG.H1; drills, burrs, trephines & accessories (simple, powered)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2562-2026Want us to check the next one for you?
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