FDA-Device2026-07-01Class IIPROCESSING DEFECT
Surgify Halo 5.4 mm spinal surgery burr recalled for breakage risk
What this means
Surgify Medical's Halo 5.4 mm burr, used in minimally invasive spinal surgery, may break during use. The company has identified this risk and is notifying healthcare facilities.
- If you use or stock this device, contact your Surgify Medical representative or supplier for guidance
- Check the model number 54.140.SHD.H1 and UDI 06429811532137 against your inventory
- Do not use affected units until Surgify issues updated instructions
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: 54.140.SHD.H1; drills, burrs, trephines & accessories (simple, powered)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2572-2026Want us to check the next one for you?
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