Class 2 Device Recall Powder, Porcelain, Porcelain Powder Blanks for Dental Restorations

• Date Initiated by Firm: August 06, 2020
• Create Date: September 09, 2020
• Recall Status: Terminated on October 07, 2022
• Recall Number: Z-2943-2020
• Recall Event ID: 86227
• 510(K)Number: K100232
• Product Classification: Powder, porcelain - Product Code EIH
• 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.
• Code Information: Lot Number.: 1AZG
• FEI Number: 2023129
• Recalling Firm/ Manufacturer: Talladium Inc; 27360 Muirfield Ln; Valencia CA 91355-1010
• For Additional Information Contact: Michael Capellan; 800-221-6449 Ext. 125
• Manufacturer 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.
• FDA Determined 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 document the amount of product you have on hand for return. A customer service representative will contact you with a Return Merchandise Authorization (RMA) Number and will provide instructions for the return of product. 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. Have the customers return any affected product to you, together with a completed Recall Acknowledgement Form, for consolidation and return to the recalling firm. Please complete the attached Acknowledgement form even if you do not have any affected stock, scan and email to productrecall@talladium.com or mail to 27360 W. Muirfield Lane, Valencia, CA 91355. ATTN: Michael Capellan  PRODUCT RECALL. You can also report an adverse event to the FDAs MedWatch Adverse Event Reporting program: A. Online at: http://www.fda.gov/safety/medwatch/howtoreport/default.htm B. Report by telephone: 1-800-FDA-1088 or Fax report: 1-800-FDA-0178. If you have any other questions, feel free to contact Michael Capellan at michael@talladium.com.
• Quantity in Commerce: 39 pieces
• Distribution: U.S. Nationwide distribution including in the states of CA, FL, KS, LA, MO, and PA. No OUS Consignees.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = EIH