Talladium Luminesse Zirconia Discs recall
Talladium Luminesse Zirconia Discs, Zirconia HT Disc 98x20mm A1, Shaded Zirconia Blend 2.0 50# A1, Model No. 5147-A1;(UDI): D7915147A10 - Product…
Why was Talladium Luminesse Zirconia Discs 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Number.: 1AZG
- Product
- Talladium Luminesse Zirconia Discs, Zirconia HT Disc 98x20mm A1, Shaded Zirconia Blend 2.0 50# A1, Model No. 5147-A1;(UDI): D7915147A10 - Product…
- Recalling firm
- Talladium Inc
- Quantity
- 39 pieces
- Distribution
- U.S. Nationwide distribution including in the states of CA, FL, KS, LA, MO, and PA. No OUS Consignees.
- Recall date
- September 16, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)