FDA Device recall Z-2516-2025
TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System
- FDA Device
- Class II
- ongoing
- Published 2025-09-10
On 2025-09-10 the FDA classified a Class II recall of TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System by Premia Spine, citing potential for missing pins at tip of inserter.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2516-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-07-16 |
| Published | 2025-09-10 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Premia Spine |
| Distribution | US |
Product
TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number: 82889.
Reason
Potential for missing pins at tip of inserter.
Identifiers
| code_info | Model Number: 82889. UDI-DI: 07290115932638. Lot Numbers: RS20220546-1, RS20222162-1, RS20171777-1, RS20171884-1, RS0431-13B-1, 20152764-1, RS0431-02-1. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2516-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.