FDA-Device2026-07-01Class IIPROCESSING DEFECT
Surgify Halo 4.0 mm surgical burr recalled for breakage risk during spinal surgery
Surgify Halo surgical burr recalled for breakage risk
Surgify Medical's Halo 4.0 mm short burr (model 40.070.NVG.H1) may break during bi-portal endoscopic spinal surgery (BESS). The breakage could occur during the procedure and compromise the surgical outcome. This affects all lots distributed in the US until updated instructions are implemented.
- If you use this burr in spinal surgery, contact Surgify Medical for updated instructions before using remaining inventory.
- Do not use affected lots until you have received and reviewed the updated instructions for use (IFU).
- Consult your institution's surgical equipment manager or Surgify Medical for guidance on affected inventory.
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, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.H1; drills, burrs, trephines & accessories (simple, powered)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2560-2026More 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 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
- FDA-Device2026-07-01Surgify Halo 5.4 mm spinal surgery burr recalled for breakage risk
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