Safety Alert: Class II: Potential for missing pins at tip of inserter.
healthClass IIRecalled on Sep 10, 2025
TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number: 82889.
🔢 30 units
Sold At: PREMIA SPINE LTD(US Nationwide distribution in the state of Connecticut.)
Recall #: FDA-DEVICE-Z-2516-2025
Source: FDA-ENFORCEMENT
Product Identification
- Lot/Batch Codes:
- Model Number: 82889. UDI-DI: 07290115932638. Lot Numbers: RS20220546-1, RS20222162-1, RS20171777-1, RS20171884-1, RS0431-13B-1, 20152764-1, RS0431-02-1.
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Summary
Potential for missing pins at tip of inserter.
What to do next
- 1Stop using this product - may cause temporary or medically reversible health problems
- 2Check with retailer or manufacturer for recall status and remedy options
- 3Contact PREMIA SPINE LTD for return or refund information
- 4Visit the official FDA recall page for complete details
Summaries only; always follow the official notice.