Z-1408-2025Class II

Premier Solo Diamond - Large Invented Cone; SKU: 807016C

Name: Z-1408-2025 Premier Solo Diamond - Large Invented Cone; SKU: 807016C
Creator: Premier Dental Products Co
Published: 2025-02-27
License: https://open.fda.gov/license/

Premier Dental Products Co / initiated 2025-02-27 / Open, Classified / root cause: manufacturing process

FDA source

Premier Dental Products Co began a recall of Premier Solo Diamond - Large Invented Cone; SKU: 807016C on 2025-02-27. FDA classified it as Class II and gives the reason as "The hardness not meeting the material specification and may cause the diamond bur to bend". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1408-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-02-27
Posted: 2025-03-21
Recalling firm: Premier Dental Products Co
Product: Premier Solo Diamond - Large Invented Cone; SKU: 807016C.
Product code: EJL Bur, Dental
Reason for recall: The hardness not meeting the material specification and may cause the diamond bur to bend.
Root cause tag: manufacturing process
FDA 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 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 ([email protected]) 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 [email protected]. We thank you for your assistance in completing this activity and apologize for any inconvenience that this may cause.
Quantity in commerce: 77 units
Distribution: US Nationwide distribution in the states of CA, MN, NY, PA, TN, VA, WA.
Product codes and lots: SKU: 807016C; UDI-DI: 00348783000237; Lot Numbers: M0117646, M0120260, M0123294;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1408-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1408-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-02	2025-03-21

Product code EJL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)