Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.U1; drills, burrs, trephines & accessories (simple, powered)
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Official details
- Category
- Medical device recall
- Status
- Ongoing
- Classification
- Class II
- Company or vendor
- SURGIFY MEDICAL OY
- Affected product
- US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.
- Risk or reason
- Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
- Remedy or action
- UDI: 06429811532311 ; All lots until the IFU update has been implemented
- Official ID
- Z-2565-2026