FDA-Device2026-07-01Class IIPROCESSING DEFECT
Surgify Halo 5.4 mm burr recalled for breakage risk during spinal surgery
What this means
Surgify Medical's Halo 5.4 mm extendable burr may break during bi-portal endoscopic spinal surgery (BESS). This surgical instrument is used by spine surgeons, and burr breakage during the procedure could complicate the operation. No injuries have been reported.
- If you are a surgeon or surgical facility using this burr model (54.000.SEE.H1), contact Surgify Medical for guidance before using remaining inventory.
- Check the device UDI (06429830116998) against your surgical supplies.
- Review the updated instructions for use (IFU) from Surgify Medical before resuming use of any replacement burrs.
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
53 units
Manufactured in
Otakaari 5 I, N/A, Espoo, N/A, Finland
Products
Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.H1; drills, burrs, trephines & accessories (simple, powered)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2564-2026Want us to check the next one for you?
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