FDA-Device2026-07-01Class IIPROCESSING DEFECT
Surgify Halo 5.4 mm surgical burr recalled for breakage risk during spinal surgery
Surgify Halo surgical burr recalled for breakage risk
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.
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, 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-2568-2026More 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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