Luminesse ML PMMA recalled over labeling errors

Recall date

October 9, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Talladium Inc recalls Luminesse ML PMMA, 98x20mm, REF: 5336-B1 - Product Usage: used as a milling blank in the fabrication of provisional cro…

Recall number

Z-0512-2021

FDA classification

Class III

Brand / firm

Talladium Inc

Sold / distributed

U.S. Nationwide distribution including in the states of PA, KS, OR, FL, CA.

Why it was recalled

Heat-cured polymethylmethacrylate (PMMA) milling blank product used to make long-term temporary crowns and bridge restorations has incorrect label. label states Part no. 5336-B1 (98x20mm). However, the item inside the box was Part no. 4302-B1 (95x20mm). An incorrect label may result in compatibility issues when setting up the disc with milling machine fixtures due to size variation.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Luminesse ML PMMA, 98x20mm, REF: 5336-B1 - Product Usage: used as a milling blank in the fabrication of provisional crowns and bridges. All blanks are solely used by a Trained Dental Technician or on the order of a dental professional.