Reported Sep 10, 2025 · Ongoing
TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number: 82889.
Premia Spine Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: PREMIA SPINE LTD · Giborey Israel 7 · Netanya, N/A · N/A
Is this the product you have?
- TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System
- Model Number82889
- Lot codes and dates
- Model Number82889
- UDI-DI07290115932638
- Lot Numbers
RS20220546-1RS20222162-1RS20171777-1RS20171884-1RS0431-13B-120152764-1RS0431-02-1
- Amount recalled
- 30 units
Where it was sold
- Nationwide
- CT
Why it was recalled
Potential for missing pins at tip of inserter.
This product could cause temporary or reversible health problems — stop using it.
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