FDA-Device2026-07-01Class IIPROCESSING DEFECT
Surgify Halo 3.0 mm burr recalled for breakage risk during spinal surgery
Surgify Halo burr recalled for breakage risk
Surgify Medical's Halo 3.0 mm burr (Model 30.125.NVG.U2) may break during bi-portal endoscopic spinal surgery (BESS). The issue affects all lots until updated instructions are implemented. No injuries have been reported.
- If your facility uses this burr, contact Surgify Medical for the updated instructions
- Do not use affected lots until instructions have been updated
- Check your spinal surgery inventory for Model 30.125.NVG.U2 with UDI 06429811532212
Hazard
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Who it affects
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, 3.0 mm, Long, Model/Catalog Number: 30.125.NVG.U2; drills, burrs, trephines & accessories (simple, powered)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2557-2026More Surgify Medical recalls
- FDA-Device2026-07-01Surgify Halo 5.4 mm burr recalled for breakage risk during spinal surgery
- FDA-Device2026-07-01Surgify Halo 40 mm spinal surgery burr recalled for breakage risk during endoscopic procedures
- FDA-Device2026-07-01Surgify Halo 4.0 mm surgical burr recalled for breakage risk during spinal surgery
- FDA-Device2026-07-01Surgify Halo 5.4 mm burr recalled for breakage risk during spinal surgery
- FDA-Device2026-07-01Surgify Halo 3.0 mm surgical burr recalled for breakage risk during spinal surgery
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