Netanya, N/A, Israel
PREMIA SPINE LTD recalls
1 recall recorded since 2018, most recently on 16 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
- 16 July 2025
- Reason
- Potential for missing pins at tip of inserter.
- Distribution
- US Nationwide distribution in the state of Connecticut.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2516-2025
- TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number: 82889.
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.