FDA-Device2026-07-01Class IIPROCESSING DEFECT
Surgify Halo 4.0 mm burr recalled for potential breakage during spinal surgery
What this means
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.
The agency's original wording
Hazard
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Intended for
Adults
Illnesses reported
None reported
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-2558-2026Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.