Z-2943-2020Class II

Talladium Luminesse Zirconia Discs, Zirconia HT Disc 98x20mm A1, Shaded Zirconia Blend 2.0 50# A1, Model No...

Name: Z-2943-2020 Talladium Luminesse Zirconia Discs, Zirconia HT Disc 98x20mm A1, Shaded Zirconia Blend 2.0 50# A1, Model No...
Creator: Talladium Inc
Published: 2020-08-06
License: https://open.fda.gov/license/

Talladium Inc / initiated 2020-08-06 / Terminated / root cause: labeling and UDI

FDA source

Talladium Inc began a recall of 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... on 2020-08-06. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2943-2020
Classification: Class II
Status: Terminated
Initiated: 2020-08-06
Posted: 2020-09-09
Terminated: 2022-10-07
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.
Product code: EIH Powder, Porcelain
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.
Root cause tag: labeling and UDI
FDA 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 [email protected], 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 [email protected] 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 [email protected].
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.
Product codes and lots: Lot Number.: 1AZG

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2943-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2943-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-16	2020-09-09

Product code EIH

K100232Class IILuminesse Zr BlanksTalladium, Inc. / cleared 2010-05-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)