Class II
Medical Device Recall: TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number: 82889.
PREMIA SPINE LTD · July 16, 2025
Reason for Recall
Potential for missing pins at tip of inserter.
Distribution
US Nationwide distribution in the state of Connecticut.
States Affected
NATIONWIDE
Quantity Affected
30 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2516-2025
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.