Goteborg, N/A, Sweden
ORTOMA AB recalls
1 recall recorded since 2018, most recently on 28 July 2025. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 28 July 2025
- Reason
- Due to a weld breakage between the pin and inserter holder of the Inserter Adapter.
- Distribution
- Worldwide - U.S. Nationwide distribution in the state of FL and the countries of Japan, Sweden.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2615-2025
- Ortoma Inserter Adapter OTD: Inserter Adapter OTD Straight REF 30-201 Model Number: 2001 UDI-DI code: 07350137521019 Inserter Adapter OTD Pinnacle Straight REF 30-202 Model Number: 1001 UDI-DI code: 0735013752059
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.