FDA DeviceClass IINotable

FDA Recall: Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.U1; drills, burrs, trephines & ac

Date: 2026-07-01

Brand: SURGIFY MEDICAL OY

Category: Medical Device

FDA Class: Class II

Description

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

Hazard

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

Remedy

8 units

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