TOPS Inserter recall
TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number: 82889.
Why was TOPS Inserter recalled?
Potential for missing pins at tip of inserter.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model Number: 82889. UDI-DI: 07290115932638. Lot Numbers: RS20220546-1, RS20222162-1, RS20171777-1, RS20171884-1, RS0431-13B-1, 20152764-1, RS0431-02-1.
- Product
- TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number: 82889.
- Recalling firm
- PREMIA SPINE LTD
- Quantity
- 30 units
- Distribution
- US Nationwide distribution in the state of Connecticut.
- Recall date
- September 10, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)