FDA DevicesClass II
Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.U1; drills, b...
Published: July 1, 2026Recall ID: Z-2565-2026Category: devicesCountry: US
Reason for Recall / Hazard
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Product Description & Identification
Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.U1; drills, burrs, trephines & accessories (simple, powered)
Additional Source Details
| Field | Value |
|---|---|
| City | Espoo |
| State | N/A |
| Event id | 98918 |
| Address 1 | Otakaari 5 I |
| Address 2 | N/A |
| Code info | UDI: 06429811532311 ; All lots until the IFU update has been implemented |
| Postal code | N/A |
| Report date | 20260701 |
| Product type | Devices |
| Product quantity | 8 units |
| Reason for recall | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260430 |
| Initial firm notification | |
| Center classification date | 20260624 |
Overview
- Recalling FirmSURGIFY MEDICAL OY
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.