FDA recall Z-2568-2026

SURGIFY MEDICAL OY · Class II · device

Product

Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.H1; burrs, trephines & accessories (simple, powered)

Reason for recall

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Distribution

US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.

Key facts

Status
Ongoing
Initiation date
2026-04-30
Report date
2026-07-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Espoo, N/A, Finland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2568-2026