Device product
Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
Z-2571-2026
Product summary
- Event
- Event 98918
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-2571-2026
Official wording
Reason: Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Code information: UDI: 06429811532304 ; 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
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).