Reported Sep 16, 2020 · Terminated
Talladium Luminesse Zirconia Discs, Zirconia HT Disc 98x20mm A1, Shaded Zirconia Blend 2.0 50# A1, Model No.…
Talladium Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Talladium Inc · 27360 Muirfield Ln · Valencia, CA · 91355-1010
Is this the product you have?
Talladium Luminesse Zirconia DiscsZirconia HT Disc 98x20mm A1Shaded Zirconia Blend 2.0 50# A1Model No. 5147-A1(UDI):
- D7915147A10 - Product Usageare 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
- Lot codes and dates
- Lot Number.: 1AZG
- Amount recalled
- 39 pieces
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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