FDA-Device2026-07-01Class IIPROCESSING DEFECT
Surgify Halo 40 mm spinal surgery burr recalled for breakage risk during endoscopic procedures
What this means
Surgify Medical's Halo 40 mm burr tool, used in minimally invasive spinal surgery, may break during the procedure. This could interrupt surgery or leave fragments in the surgical site. The recall affects all units until the manufacturer updates instructions for use.
- If you use this burr in your facility, stop using affected lots immediately.
- Contact Surgify Medical for updated instructions or replacement units.
- Review your surgical inventory for Model 40.125.NVG.U1 (UDI: 06429811532274).
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, 40 mm, Long, Model/Catalog Number: 40.125.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2563-2026Want us to check the next one for you?
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