FDA-Device2026-07-01Class IIPROCESSING DEFECT
Surgify Halo 5.4 mm spinal surgery burr recalled for breakage risk
OTHERNationwide distribution
Surgify Halo burr recalled for breakage risk in spinal surgery
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.
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, 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-2566-2026More 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 4.0 mm spinal surgery burr recalled for breakage risk
- FDA-Device2026-07-01Surgify Halo 5.4 mm spinal surgery burr recalled for breakage risk
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