FDA-Device2026-07-01Class IIPROCESSING DEFECT
Surgify Halo 4.0 mm spinal surgery burr recalled for breakage risk
What this means
Surgify Medical's Halo 4.0 mm extendable burr, used in spinal surgery, may break during the procedure. The breakage could occur during bi-portal endoscopic spinal surgery (BESS). This affects all lots until the manufacturer updates the product instructions.
- If you use or stock this burr (model 40.000.SEE.U1), contact Surgify Medical or your surgical supplier for guidance.
- Do not use affected units until the manufacturer provides updated instructions.
- Report any breakage incidents to the FDA and Surgify Medical.
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, Extendable, Model/Catalog Number: 40.000.SEE.U1; drills, burrs, trephines & accessories (simple, powered)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2559-2026Want us to check the next one for you?
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