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 extendable burr (Model 40.000.SEE.H1) may break during bi-portal endoscopic spinal surgery (BESS). The breakage could occur during the procedure and potentially complicate the surgery. This affects 112 units distributed across several US states.
- If you use this burr in surgical procedures, contact Surgify Medical for instructions before your next use.
- Do not use affected lots until you receive updated instructions from the manufacturer.
- Report any incidents of burr breakage to Surgify Medical and the FDA.
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
112 units
Manufactured in
Otakaari 5 I, N/A, Espoo, N/A, Finland
Products
Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.H1; drills, burrs, trephines & accessories (simple, powered)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2558-2026More 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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