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.

Recall number

Z-2943-2020

Recalling firm

Talladium Inc

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.

Status

Terminated

Initiated

2020-08-06

Posted

not on file

Terminated

2022-10-07

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 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

39 pieces

Distribution

U.S. Nationwide distribution including in the states of CA, FL, KS, LA, MO, and PA. No OUS Consignees.

Lot, serial or model codes

Lot Number.: 1AZG

510(k) numbers

["K100232"]

PMA numbers

not on file

Product code

EIH

Firm FEI

2023129

Firm city

Valencia

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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