Premier Dental Products Co: Medical Device Recall in 2025 - (Recall #: Z-1408-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: February 27, 2025

Date Posted: April 2, 2025

Recall Number: Z-1408-2025

Event ID: 96394

Reason for Recall:

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

Status: Ongoing

Product Quantity: 77 units

Code Information:

SKU: 807016C; UDI-DI: 00348783000237; Lot Numbers: M0117646, M0120260, M0123294;

Distribution Pattern:

US Nationwide distribution in the states of CA, MN, NY, PA, TN, VA, WA.

Voluntary or Mandated:

Voluntary: Firm initiated