Class II — PREMIA SPINE LTD
| Recalling firm | Premia Spine Ltd. |
|---|---|
| Registered facility | PREMIA SPINE LTD. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Potential for missing pins at tip of inserter. |
| Product | TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number: 82889. |
| Quantity | 30 units |
| Distribution | US Nationwide distribution in the state of Connecticut. |
| Initiated | 2025-07-16 |
| Classified | 2025-09-04 |
| Recall number | Z-2516-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — PREMIA SPINE LTD (Z-2516-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97367/
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