Talladium Inc: Medical Device Recall in 2020 - (Recall #: Z-2943-2020)

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:

Talladium Luminesse Zirconia Discs, Zirconia HT Disc 98x20mm A1, Shaded Zirconia Blend 2.0 50# A1, Model No. 5147-A1;(UDI): D7915147A10 - Product Usage: are intended for CAD/CAM fabrication of all-ceramic (no metal) dental restorations. Luminesse ZR Blanks are partially sintered Yttria stabilized zirconia blanks for use as CAD/CAM milling blanks.

Product Classification:

Class II

Date Initiated: August 6, 2020

Date Posted: September 16, 2020

Recall Number: Z-2943-2020

Event ID: 86227

Reason for Recall:

The linear shrinkage on the zirconia blank disc s part label is incorrect. The average linear shrinkage found on the product label was outside the acceptable range. The acceptable average linear shrinkage ranges between 1.225 to 1.275. The production lot being recalled has a linear shrinkage rate of 2.251 which is above the acceptable range.

Status: Terminated

Product Quantity: 39 pieces

Code Information:

Lot Number.: 1AZG

Distribution Pattern:

U.S. Nationwide distribution including in the states of CA, FL, KS, LA, MO, and PA. No OUS Consignees.

Voluntary or Mandated:

Voluntary: Firm initiated