Recall Z-1408-2025 ยท EJL Bur, Dental
Premier Dental Products Co
Premier Solo Diamond - Large Invented Cone; SKU: 807016C.
| Date | Mar 21, 2025 (initiated Feb 27, 2025) |
| Status | Open, Classified |
| Reason | The hardness not meeting the material specification and may cause the diamond bur to bend. |
| Root cause | Process control |
| Action | On February 25, 2025 MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken: Immediately examine your inventory and quarantine all product subject to this recall, including individual bottles in partial boxes. This recall should be carried out to the healthcare practitioner level. If you have further distributed this product, please identify and notify all your customers that received the affected SKU and lot numbers of this product at once. You may include a copy of this notification with your communication to your customers that have received affected product. Please have |
| Quantity | 77 units |
| Distribution | US Nationwide distribution in the states of CA, MN, NY, PA, TN, VA, WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.