Drug recall
Surgify Halo, 3.0 mm, Extendable, Model/Catalog Number: 30.000.SEE.U2; drills, burrs, trephines & accessories…
FDA recall event 98918 · Class II · SURGIFY MEDICAL OY
Key facts
| Event ID | 98918 |
|---|---|
| Recall numbers | Z-2555-2026, Z-2556-2026, Z-2557-2026, Z-2558-2026, Z-2559-2026, Z-2560-2026, Z-2561-2026, Z-2562-2026, Z-2563-2026, Z-2564-2026, Z-2565-2026, Z-2566-2026 and 7 more |
| Recalling firm | SURGIFY MEDICAL OY |
| Product type | Devices |
| Products | Surgify Halo, 3.0 mm, Extendable, Model/Catalog Number: 30.000.SEE.U2; drills, burrs, trephines & accessories (simple, powered), Surgify Halo, 3.0 mm, Long, Model/Catalog Number: 30.125.NVG.U2; drills, burrs, trephines & accessories (simple, powered), Surgify Halo, 3.0 mm, Short, Model/Catalog Number: 30.070.NVG.U2; drills, burrs, trephines & accessories (simple, powered), Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.H1; drills, burrs, trephines & accessories (simple, powered), Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.U1; drills, burrs, trephines & accessories (simple, powered) and 14 more |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). |
| Initiation date | Apr 30, 2026 |
| Report date | Jul 1, 2026 |
| City | Espoo |
| Country | Finland |
| FEI number | 3015392173 |
At a glance
- 10–99 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: