Z-1408-2025 Class II Ongoing
FDA device recall Z-1408-2025 was initiated by Premier Dental Products Co on February 27, 2025 and is designated Class II. Reason for recall: The hardness not meeting the material specification and may cause the diamond bur to bend. The recall status is ongoing. Affected quantity: 77 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 2, 2025
- Initiation Date
- February 27, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 77 units
Product Description
Premier Solo Diamond - Large Invented Cone; SKU: 807016C.
Reason for Recall
The hardness not meeting the material specification and may cause the diamond bur to bend.
Distribution Pattern
US Nationwide distribution in the states of CA, MN, NY, PA, TN, VA, WA.
Code Information
SKU: 807016C; UDI-DI: 00348783000237; Lot Numbers: M0117646, M0120260, M0123294;