Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
TOPS Inserter Recalled by PREMIA SPINE LTD Due to Potential for missing pins at tip of inserter.
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact PREMIA SPINE LTD directly.
Affected Products
TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number: 82889.
Quantity: 30 units
Why Was This Recalled?
Potential for missing pins at tip of inserter.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About PREMIA SPINE LTD
PREMIA SPINE LTD has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report