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 the procedure. The company has identified this risk and is recalling affected units.
- If you use this burr in surgical procedures, contact Surgify Medical or your distributor for updated instructions or replacement units.
- Do not use affected burrs (Model 54.085.SHD.U1) until you receive confirmation of the fix or a replacement.
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, Medium, Model/Catalog Number: 54.085.SHD.U1; drills, burrs, trephines & accessories (simple, powered)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2569-2026Want us to check the next one for you?
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