FDA-Device2026-07-01Class IIPROCESSING DEFECT
Surgify Halo 5.4 mm spinal surgery burr recalled for breakage risk
What this means
Surgify Medical's Halo 5.4 mm burr, used in minimally invasive spinal surgery, may break during the procedure. This affects spinal surgery burrs distributed across the US.
- If you use this burr in spinal surgery, contact Surgify Medical or your surgical supplier for updated instructions or a replacement.
- Review the product's instructions for use (IFU) update when available.
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, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.H1; drills, burrs, trephines & accessories (simple, powered)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2566-2026Want us to check the next one for you?
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