Medical DeviceSep 10, 2025
PREMIA SPINE TOPS Inserter, part of the TOPS System Instrument Set used for implantation of recall — FDA Z-2516-2025
Potential for missing pins at tip of inserter.
Class IIFDA: OngoingPREMIA SPINE LTD
Recall history in this database
Classification mix: Class II: 1.
Understanding this recall history
This page summarizes recall records in which the official source identifies PREMIA SPINE LTD as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.