FDA-Device2026-07-01Class IIPROCESSING DEFECT
Surgify Halo 4.0 mm spinal surgery burr recalled for breakage risk
OTHERNationwide distribution
Surgify Halo surgical burr recalled for breakage risk
Surgify Medical's Halo 4.0 mm burr, used in spinal surgery, may break during the procedure. The affected model is 40.070.NVG.U1. This issue affects all lots currently distributed until the manufacturer updates its instructions.
- If your facility uses this burr model, contact Surgify Medical for guidance on the instruction update
- Do not use affected units until you have confirmed receipt of updated instructions from the manufacturer
Hazard
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
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.U1; drills, burrs, trephines & accessories (simple, powered)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2561-2026More SURGIFY MEDICAL OY recalls
- FDA-Device2026-07-01Surgify Halo 5.4 mm surgical burr recalled for breakage risk during spinal surgery
- FDA-Device2026-07-01Surgify Halo 4.0 mm burr recalled for potential breakage during spinal surgery
- FDA-Device2026-07-01Surgify Halo 4.0 mm burr recalled for potential breakage during spinal surgery
- FDA-Device2026-07-01Surgify Halo 5.4 mm spinal surgery burr recalled for breakage risk
- FDA-Device2026-07-01Surgify Halo 5.4 mm extendable burr recalled for breakage risk during spinal surgery
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