FDA-Device2026-07-01Class IIPROCESSING DEFECT
Surgify Halo 4.0 mm surgical burr recalled for breakage risk during spinal surgery
What this means
Surgify Medical's Halo 4.0 mm short burr (model 40.070.NVG.H1) may break during bi-portal endoscopic spinal surgery (BESS). The breakage could occur during the procedure and compromise the surgical outcome. This affects all lots distributed in the US until updated instructions are implemented.
- If you use this burr in spinal surgery, contact Surgify Medical for updated instructions before using remaining inventory.
- Do not use affected lots until you have received and reviewed the updated instructions for use (IFU).
- Consult your institution's surgical equipment manager or Surgify Medical for guidance on affected inventory.
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, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.H1; drills, burrs, trephines & accessories (simple, powered)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2560-2026Want us to check the next one for you?
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