Class II
Medical Device Recall: Premier Solo Diamond - Large Invented Cone; SKU: 807016C.
Premier Dental Products Co · February 27, 2025
Reason for Recall
The hardness not meeting the material specification and may cause the diamond bur to bend.
Distribution
US Nationwide distribution in the states of CA, MN, NY, PA, TN, VA, WA.
States Affected
NATIONWIDE
Quantity Affected
77 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1408-2025
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.