FDA Enforcement
Class II
Ongoing
Premier Solo Diamond - Large Invented Cone; SKU: 807016C.
Recall: Z-1408-2025
·
Reported April 2, 2025
Enforcement
- Recall Number
- Z-1408-2025
- Event ID
- 96394
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Premier Dental Products Co
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 2, 2025
- Initiation Date
- February 27, 2025
- Classification Date
- March 21, 2025
- Address
- 1710 Romano Dr, N/A, Plymouth Meeting, PA, 19462-2822, United States
Description
Premier Solo Diamond - Large Invented Cone; SKU: 807016C.
Reason
The hardness not meeting the material specification and may cause the diamond bur to bend.
Code Info
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.
Quantity
77 units