Talladium Luminesse Zirconia Discs — Class II medical device recall Z-2943-2020
Terminated recall by Talladium Inc, reported 2020-09-16, distributed nationwide. The linear shrinkage on the zirconia blank disc s part label is incorrect. The average linear shrinkage found
| Recall number | Z-2943-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Talladium Inc, Valencia, CA, United States |
| Recall initiated | 2020-08-06 |
| Classified | 2020-09-09 |
| Reported by FDA | 2020-09-16 |
| Terminated | 2022-10-07 |
| Distributed | Nationwide (US) |
| Quantity | 39 units |
| Reason classes | labeling |
| Lot numbers | 1AZG |
| Model numbers | 5147-A1 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2943-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.