Device recall
Z-2516-2025: TOPS Inserter, part of the TOPS System Instrument Set used for implantation of…
FDA device recall · Class II · PREMIA SPINE LTD
Key facts
| Recall number (Z-number) | Z-2516-2025 |
|---|---|
| Recall event | 97367 |
| Product | TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number: 82889. |
| Product code | QWK |
| Recalling firm | PREMIA SPINE LTD |
| Recall class | Class II |
| Status | Open, Classified |
| PMA numbers | P220002 |
| FEI number | 3012401682 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database