FDA Medical devices recall ·
Premier Solo Diamond - Large Invented Cone recall
- Recall number
- Z-1408-2025
- Date
- (initiated February 27, 2025)
- Company / brand
- Premier Dental Products Co
1710 Romano Dr, Plymouth Meeting, PA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 77 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Premier Solo Diamond - Large Invented Cone; SKU: 807016C.
Why was it recalled?
The hardness not meeting the material specification and may cause the diamond bur to bend.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
SKU: 807016C; UDI-DI: 00348783000237; Lot Numbers: M0117646, M0120260, M0123294;
Distribution
US Nationwide distribution in the states of CA, MN, NY, PA, TN, VA, WA.
States: California Minnesota New York Pennsylvania Tennessee Virginia Washington
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1408-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.