Medical device recalls Moderate risk

Premier Dental Products Co recalls Premier Solo Diamond - Large Invented Cone; SKU: 807016C.

Recall date
February 27, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1408-2025
FDA classification
Class II
Brand / firm
Premier Dental Products Co
Sold / distributed
US Nationwide distribution in the states of CA, MN, NY, PA, TN, VA, WA.

Why it was recalled

The hardness not meeting the material specification and may cause the diamond bur to bend.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Premier Solo Diamond - Large Invented Cone; SKU: 807016C.

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