PREMIA SPINE LTD: Device Recall
Recall #Z-2516-2025 · 07/16/2025
Class II: Risk
Recall Details
- Recall Number
- Z-2516-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- PREMIA SPINE LTD
- Status
- Ongoing
- Date Initiated
- 07/16/2025
- Location
- Netanya, N/A, Israel
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30 units
Reason for Recall
Potential for missing pins at tip of inserter.
Product Description
TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number: 82889.
Distribution Pattern
US Nationwide distribution in the state of Connecticut.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.