Talladium Luminesse Zirconia Discs Recalled for Incorrect Shrinkage Labeling
Talladium Inc is recalling 39 Luminesse Zirconia Discs because the linear shrinkage value on the label is incorrect and outside the acceptable range.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves incorrect labeling of a physical property (linear shrinkage) rather than a direct toxicological or mechanical failure, fitting the criteria for moderate severity involving labeling errors.
Plain-English summary
Talladium Inc is recalling 39 pieces of Talladium Luminesse Zirconia Discs, Model No. 5147-A1, Lot Number 1AZG. These products are intended for the CAD/CAM fabrication of all-ceramic dental restorations. The recall is due to an error in the product labeling regarding the material's physical properties.
The linear shrinkage value printed on the product label is incorrect. The acceptable average linear shrinkage for these discs ranges between 1.225 and 1.275. However, the production lot being recalled has a linear shrinkage rate of 2.251, which is above the acceptable range. This discrepancy means the label does not accurately reflect the product's specifications.
The affected products were distributed nationwide in the United States, including in California, Florida, Kansas, Louisiana, Missouri, and Pennsylvania. There are no overseas consignees. Consumers and dental laboratories should stop using these specific discs and contact Talladium Inc for further instructions.
The recalled product
- 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…
- Manufacturer
- Talladium Inc
- Hazard
- Affected units
- 39
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number.: 1AZG
Distribution
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