Talladium Inc: Medical Device Recall in 2020 - (Recall #: Z-0512-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class III

Date Initiated: October 9, 2020

Date Posted: December 9, 2020

Recall Number: Z-0512-2021

Event ID: 86614

Reason for Recall:

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.

Status: Terminated

Product Quantity: 10

Code Information:

Lot No. 1BKI

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated