Premier Dental Products Co: Device Recall

Recall #Z-1408-2025 · 02/27/2025

Class II: Risk

Recall Details

Recall Number
Z-1408-2025
Classification
Class II
Product Type
Device
Recalling Firm
Premier Dental Products Co
Status
Ongoing
Date Initiated
02/27/2025
Location
Plymouth Meeting, PA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
77 units

Reason for Recall

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

Product Description

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

Distribution Pattern

US Nationwide distribution in the states of CA, MN, NY, PA, TN, VA, WA.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.