FDA-Device2026-07-01Class IIPROCESSING DEFECT
Surgify Halo 5.4 mm burr recalled for breakage risk during spinal surgery
Surgify Halo burr recalled for breakage risk in spinal surgery
Surgify Medical's Halo 5.4 mm burr (Model 54.070.NVG.U1) may break during bi-portal endoscopic spinal surgery (BESS). The risk affects all lots distributed in the U.S. until updated instructions are provided.
- If you use this burr in surgical procedures, contact Surgify Medical for updated instructions before further use.
- Review the device serial number and lot information against the FDA recall notice.
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, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2567-2026More 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 3.0 mm surgical burr recalled for breakage risk during spinal surgery
- FDA-Device2026-07-01Surgify Halo 5.4 mm spinal surgery burr recalled for breakage risk
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