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U.S. Department of Health and Human Services

Class 2 Device Recall Premier Solo Diamond

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 Class 2 Device Recall Premier Solo Diamondsee related information
Date Initiated by FirmFebruary 27, 2025
Date PostedMarch 21, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1408-2025
Recall Event ID 96394
Product Classification Bur, dental - Product Code EJL
ProductPremier Solo Diamond - Large Invented Cone; SKU: 807016C.
Code Information SKU: 807016C; UDI-DI: 00348783000237; Lot Numbers: M0117646, M0120260, M0123294;
Recalling Firm/
Manufacturer		 Premier Dental Products Co
1710 Romano Dr
Plymouth Meeting PA 19462-2822
For Additional Information ContactJessica Huang
610-239-6000
Manufacturer Reason
for Recall		The hardness not meeting the material specification and may cause the diamond bur to bend.
FDA Determined
Cause 2		Process control
ActionOn 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.
Quantity in Commerce77 units
DistributionUS Nationwide distribution in the states of CA, MN, NY, PA, TN, VA, WA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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