FDA-Device2026-07-01Class IIPROCESSING DEFECT
Surgify Halo 5.4 mm spinal surgery burr recalled for breakage risk
Surgify Halo burr recalled for breakage during spinal surgery
Surgify Medical's Halo 5.4 mm burr (Model 54.140.SHD.U1) used in spinal surgery may break during the procedure. This could leave fragments inside the surgical site or require additional intervention. The issue affects all lots distributed in the US until an updated instruction document is provided.
- If you use this burr in your facility, contact Surgify Medical immediately for the updated instructions before resuming use.
- Check your inventory for Model 54.140.SHD.U1 (UDI: 06429811532335) and quarantine until you receive the corrective action.
- Review any recent procedures using this burr for potential complications.
Hazard
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Who it affects
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.U1; drills, burrs, trephines & accessories (simple, powered)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2573-2026More Surgify Medical recalls
- FDA-Device2026-07-01Surgify Halo 5.4 mm burr recalled for breakage risk during spinal surgery
- FDA-Device2026-07-01Surgify Halo 40 mm spinal surgery burr recalled for breakage risk during endoscopic procedures
- FDA-Device2026-07-01Surgify Halo 4.0 mm surgical burr recalled for breakage risk during spinal surgery
- FDA-Device2026-07-01Surgify Halo 5.4 mm burr recalled for breakage risk during spinal surgery
- FDA-Device2026-07-01Surgify Halo 3.0 mm surgical burr recalled for breakage risk during spinal surgery
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