medical Class II Updated 2020-09-16

Talladium Inc recalls Talladium Luminesse Zirconia Discs, Zirconia HT Disc 98x20mm

Recalled Product

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.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Number.: 1AZG
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →