SURGIFY MEDICAL OY recalls Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG
See all recalls from SURGIFY MEDICAL OY →Recalled Product
Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
Hazard / Issue
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: UDI: 06429811532304 ; All lots until the IFU update has been implemented
✅ What Should You Do?
- 1Contact your healthcare provider immediately to discuss this recall.
- 2Stop using the device if it is safe to do so, and contact your provider.
- 3Follow the manufacturer's remedy instructions provided in the recall notice.
- 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
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