FDA-Device2026-07-01Class IIPROCESSING DEFECT
Surgify Halo 5.4 mm extendable burr recalled for breakage risk during spinal surgery
What this means
Surgify Medical's Halo 5.4 mm extendable burr (Model 54.000.SEE.U1) may break during bi-portal endoscopic spinal surgery (BESS). The defect affects 8 units distributed across the US. No injuries have been reported.
- If you use this device in spinal surgery, stop using the affected lot and contact Surgify Medical for instructions.
- Check your device's UDI (06429811532311) and lot number against the recall notice.
- Do not use the device until the manufacturer's updated instructions have been implemented.
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
8 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.U1; drills, burrs, trephines & accessories (simple, powered)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2565-2026Want us to check the next one for you?
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