Premier Solo Diamond - Large Invented Cone recall
Premier Solo Diamond - Large Invented Cone; SKU: 807016C.
Why was Premier Solo Diamond - Large Invented Cone recalled?
The hardness not meeting the material specification and may cause the diamond bur to bend.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
SKU: 807016C; UDI-DI: 00348783000237; Lot Numbers: M0117646, M0120260, M0123294;
- Product
- Premier Solo Diamond - Large Invented Cone; SKU: 807016C.
- Recalling firm
- Premier Dental Products Co
- Quantity
- 77 units
- Distribution
- US Nationwide distribution in the states of CA, MN, NY, PA, TN, VA, WA.
- Recall date
- April 2, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)