ORTOMA AB
ORTOMA AB appears in FDA public data with 1 recall, 4 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2615-2025, Class II) was initiated on July 28, 2025. Its most recent 510(k) clearance was granted on July 1, 2026.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 4
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2615-2025 | Class II | Ortoma Inserter Adapter OTD: Inserter Adapter OTD Straight REF 30-201 Model Number: 2001 UDI-DI c | July 28, 2025 |