Z-2560-2026 Class II Ongoing
FDA device recall Z-2560-2026 was initiated by SURGIFY MEDICAL OY on April 30, 2026 and is designated Class II. Reason for recall: Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). The recall status is ongoing. Affected quantity: N/A.
Recall Details
- Product Type
- Devices
- Report Date
- July 1, 2026
- Initiation Date
- April 30, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.H1; drills, burrs, trephines & accessories (simple, powered)
Reason for Recall
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Distribution Pattern
US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.
Code Information
UDI06429811532069; All lots until the IFU update has been implemented