FDA-Device2026-07-01Class IIPROCESSING DEFECT
Surgify Halo 4.0 mm burr recalled for potential breakage during spinal surgery
OTHERNationwide distribution
Surgify Halo burr recalled for breakage risk in spinal surgery
Surgify Medical's Halo 4.0 mm burr (Model 40.125.NVG.H1) may break during bi-portal endoscopic spinal surgery (BESS). The breakage could occur while the burr is in use, potentially affecting the procedure.
- If you use or have this burr in your facility, contact Surgify Medical for updated instructions before using any remaining stock.
- Do not use affected burrs until you receive the updated instructions.
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
0
Manufactured in
Otakaari 5 I, N/A, Espoo, N/A, Finland
Products
Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.125.NVG.H1; drills, burrs, trephines & accessories (simple, powered)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2562-2026More 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 spinal surgery burr recalled for breakage risk
- 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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