TOPS Inserter — Class II medical device recall Z-2516-2025
Ongoing recall by PREMIA SPINE LTD, reported 2025-09-10, distributed nationwide. Potential for missing pins at tip of inserter.
| Recall number | Z-2516-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | PREMIA SPINE LTD, Netanya, N/A, Israel |
| Recall initiated | 2025-07-16 |
| Classified | 2025-09-04 |
| Reported by FDA | 2025-09-10 |
| Distributed | Nationwide (US) |
| Quantity | 30 units |
| UPC / GTIN / UDI-DI | 07290115932638 |
| Lot numbers | 20152764-1, RS0431-02-1, RS0431-13B-1, RS20171777-1, RS20171884-1, RS20220546-1, RS20222162-1 |
| Model numbers | 82889 |
Product
TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number: 82889.
Reason for recall
Potential for missing pins at tip of inserter.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2516-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.