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Recall Observatory FDA recall evidence

Device product

Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.H1; drills, burrs, trephines & accessories (simple, powered)

Z-2570-2026

April 30, 2026

Class II

Product summary

Firm
SURGIFY MEDICAL OY
Event
Event 98918
Status
Ongoing
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-2570-2026

Official wording

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

Code information: UDI: 06429811532106 ; All lots until the IFU update has been implemented

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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