Gothenburg, SE · 3 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| OLO | Orthopedic Stereotaxic Instrument | Class II | Neurology | 3 | 2026-07-01 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2025-07-28 | Class II | Ongoing | Z-2615-2025 | Ortoma Inserter Adapter OTD: Inserter Adapter OTD Straight REF 30-201 Model Number: 2001 UDI-DI code: 07350137521019 … | — | Due to a weld breakage between the pin and inserter holder of the Inserter Adapter. |