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 burr (model 54.125.NVG.U1) may break during bi-portal endoscopic spinal surgery. The company has identified this risk and is working to update instructions for use. No injuries have been reported.
- If you use this burr in spinal surgery, contact Surgify Medical or your distributor for updated instructions before use.
- Do not use affected burrs until you have received the updated instructions for use.
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
N/A
Manufactured in
Otakaari 5 I, N/A, Espoo, N/A, Finland
Products
Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2571-2026Want us to check the next one for you?
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