Device product
TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number: 82889.
Z-2516-2025
Product summary
- Firm
- PREMIA SPINE LTD
- Event
- Event 97367
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 30 units
- Official record key
device-enforcement:Z-2516-2025
Official wording
Reason: Potential for missing pins at tip of inserter.
Code information: Model Number: 82889. UDI-DI: 07290115932638. Lot Numbers: RS20220546-1, RS20222162-1, RS20171777-1, RS20171884-1, RS0431-13B-1, 20152764-1, RS0431-02-1.
Distribution pattern: US Nationwide distribution in the state of Connecticut.
Derived failure modes
-
Unknown
Potential for missing pins at tip of inserter.