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PREMIA SPINE LTD recalls TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number: 82889.
Recalled September 10, 2025 · FDA recall Z-2516-2025 · PREMIA SPINE
Hazard
Potential for missing pins at tip of inserter. · FDA Class II
Units
30 units
Sold at
US Nationwide distribution in the state of Connecticut.
Description
Potential for missing pins at tip of inserter.
Product
TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number: 82889.
Manufacturer(s)
PREMIA SPINE LTD
Made in
Israel
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →