# FDA recall Z-2943-2020

> **Talladium Inc** · Class II · device recall initiated 2020-08-06.

## 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.

## 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.

## Distribution

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

## Key facts

- **Recall number:** Z-2943-2020
- **Recalling firm:** Talladium Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-08-06
- **Report date:** 2020-09-16
- **Termination date:** 2022-10-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Valencia, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2943-2020

## Citation

> AI Analytics. FDA recall Z-2943-2020. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2943-2020. Source: US FDA. Licensed CC0.

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