Solo Diamond Cone (Premier Dental) – Material Hardness Issue (2025)

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

The hardness not meeting the material specification and may cause the diamond bur to bend.

Recommended Action

Per FDA guidance

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 your customers account for all product in their possession and arrange for the return of all affected product. Your customers should return the affected product to you for consolidation first prior to returning to Premier Dental Products Company. Please complete the enclosed Required Recall Notice Response form and return to Premier immediately via email (regulatory@premierdentalco.com) or mail with the returned product to: Premier Solo Diamond Attn: Jessica Huang Premier Dental Products Company 1710 Romano Drive Plymouth Meeting, PA 19462 Upon receipt of the returned product at Premier Dental, Premier s Customer Experience can issue a credit or Premier can replace the returned item with SKU 807018C - SOLO Diamond Large Inverted Cone. If you have any further questions regarding billing or replacements, please contact Customer Experience at info@premierdentalco.com. We thank you for your assistance in completing this activity and apologize for any inconvenience that this may cause.