FDA recall Z-1408-2025

Product

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

Reason for recall

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

Distribution

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

Key facts

Status

Ongoing

Initiation date

2025-02-27

Report date

2025-04-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Plymouth Meeting, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1408-2025