Class II — Talladium Inc
| Recalling firm | TALLADIUM, INC. |
|---|---|
| Registered facility | TALLADIUM, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| 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. |
| Quantity | 39 pieces |
| Distribution | U.S. Nationwide distribution including in the states of CA, FL, KS, LA, MO, and PA. No OUS Consignees. |
| Initiated | 2020-08-06 |
| Classified | 2020-09-09 |
| Terminated | 2022-10-07 |
| Recall number | Z-2943-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Talladium Inc (Z-2943-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86227/
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