Drug recall
Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments: Navigation Driver, REF…
FDA recall event 97973 · Class II · SEASPINE ORTHOPEDICS CORPORATION
Key facts
| Event ID | 97973 |
|---|---|
| Recall numbers | Z-0937-2026 |
| Recalling firm | SEASPINE ORTHOPEDICS CORPORATION |
| Product type | Devices |
| Products | Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments: Navigation Driver, REF: PC2-400012; Navigation Straight Bone Probe, REF: PC2-400013; Navigation, 3.5mm Drill, REF… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The NorthStar OCT Navigation Surgical Technique Guide (STG) incorrectly identified both Medtronic s Solera and Medtronic s Infinity system toolcards as compatible with the NorthStar OCT Navigation… |
| Initiation date | Nov 17, 2025 |
| Report date | Dec 24, 2025 |
| City | Carlsbad |
| State | CA |
| Country | United States |
| FEI number | 3012120772 |
At a glance
- 1–9 Products in this recall
- 1–9 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: