Recall Z-2943-2020 ยท EIH Powder, Porcelain
Talladium Inc
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.
| Date | Aug 6, 2020 |
| 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. |
| Root cause | Under Investigation by firm |
| Action | The recall notification letters were sent on 08/12/2020, via FedEx Priority Overnight. The following is included in the recall notification as actions required: Immediately check your stock and quarantine the affected stock on hand to prevent further use. Using the provided customer letter and Recall Acknowledgement Form templates, communicate this recall to any of your customers who have received product included within the scope of the recall. To return product, complete the Recall Acknowledgement Form, scan and email to productrecall@talladium.com, Attn: Michael Capellan. This will allow to |
| Quantity | 39 pieces |
| Distribution | U.S. Nationwide distribution including in the states of CA, FL, KS, LA, MO, and PA. No OUS Consignees. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100232 | LUMINESSE ZR BLANKS Talladium, Inc., May 21, 2010 |