FDA-Device2026-07-01Class IIPROCESSING DEFECT
Surgify Halo 4.0 mm spinal surgery burr recalled for breakage risk
Surgify Halo spinal burr recalled for breakage risk
Surgify Medical's Halo 4.0 mm extendable burr, used in spinal surgery, may break during the procedure. The breakage could occur during bi-portal endoscopic spinal surgery (BESS). This affects all lots until the manufacturer updates the product instructions.
- If you use or stock this burr (model 40.000.SEE.U1), contact Surgify Medical or your surgical supplier for guidance.
- Do not use affected units until the manufacturer provides updated instructions.
- Report any breakage incidents to the FDA and Surgify Medical.
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, Extendable, Model/Catalog Number: 40.000.SEE.U1; drills, burrs, trephines & accessories (simple, powered)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2559-2026More 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 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
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