FDA-Device2026-07-01Class IIPROCESSING DEFECT
Surgify Halo 5.4 mm surgical burr recalled for breakage risk during spinal surgery
What this means
Surgify Medical's Halo 5.4 mm surgical burr (Model 54.085.SHD.H1) may break during bi-portal endoscopic spinal surgery. The risk affects all product lots distributed in the US until updated instructions are implemented.
- If you use this device in a surgical setting, contact Surgify Medical or your distributor for updated instructions before using remaining inventory.
- Do not use affected lots until instructed otherwise by the manufacturer.
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.H1; burrs, trephines & accessories (simple, powered)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2568-2026Want us to check the next one for you?
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