FDAHealthJuly 16, 2025
PREMIA SPINE LTD — TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number: 82889.
⚠️ Potential for missing pins at tip of inserter.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- July 16, 2025
US Nationwide distribution in the state of Connecticut.
What's affected?
- Product
- TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number: 82889.
- Brand
- PREMIA SPINE LTD
- Lot code
- RS20220546-1
Additional details
Model Number: 82889. UDI-DI: 07290115932638. Lot Numbers: RS20220546-1, RS20222162-1, RS20171777-1, RS20171884-1, RS0431-13B-1, 20152764-1, RS0431-02-1.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 30 units.
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