Skip to content
Lower risk Medical device recall · FDA · Published August 6, 2020

Talladium Luminesse Zirconia Discs: Incorrect Shrinkage Label Risk

Talladium Inc recalls specific zirconia dental discs due to incorrect linear shrinkage label. The product's shrinkage rate exceeds acceptable levels, potentially affecting dental restoration accuracy.

🇺🇸 FDA recall #Z-2943-2020Medical deviceTalladium ›
Take action

Contact the company

Recalling firmTalladium Inc27360 Muirfield Ln · Valencia, CA 91355-1010
✎ GovInfoNow plain-language explainer

Talladium Inc is recalling certain zirconia dental discs because their label shows an incorrect linear shrinkage rate. This could lead to dental restorations being inaccurate or improperly fitted. Read more at govinfonow.com/recall/64518-talladium-luminesse-zirconia-discs-incorrect-shrinkage-label-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/64518-talladium-luminesse-zirconia-discs-incorrect-shrinkage-label-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2943-2020

Cite this page

“Talladium Luminesse Zirconia Discs: Incorrect Shrinkage Label Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64518-talladium-luminesse-zirconia-discs-incorrect-shrinkage-label-risk. Based on FDA recall #Z-2943-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2943-2020%22&limit=1).

The FDA announced on August 6, 2020, that Talladium Inc voluntarily recalled Talladium Luminesse Zirconia Discs due to incorrect linear shrinkage data on the product label. The agency classified the recall as Class II.

How to tell if you have it

  • Brand: Talladium
  • Product: Talladium Luminesse Zirconia Discs, Zirconia HT Disc 98x20mm A1, Shaded Zirconia Blend 2.0 50# A1
  • Model No.: 5147-A1
  • UDI: D7915147A10
  • Lot Number: 1AZG

The hazard

The FDA stated that the average linear shrinkage found on the product label was outside the acceptable range of 1.225 to 1.275. The production lot being recalled has a linear shrinkage rate of 2.251, which is above the acceptable range.

Context

GovInfoNow's records show Talladium Inc has one other recall on record since October 9, 2020. On October 9, 2020, Talladium recalled Luminesse ML PMMA Milling Blanks due to an incorrect label stating Part no. 5336-B1. Other recent recalls of similar products include Straumann Bone Level Tapered Implant May Be Wrong Length (July 16, 2026) and Zeiss Intrabeam Spherical Applicator 1.5 cm Recall: Manufacturing Defect (June 1, 2026).

How to tell if you have this one

Check for the model number 5147-A1 and lot number 1AZG on the disc packaging. The product is sold as Talladium Luminesse Zirconia Discs for dental CAD/CAM use.

  • Brand
    Talladium
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Label

    Verify the model number 5147-A1 and lot number 1AZG on the disc packaging.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 6 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: named in the noticePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: named in the noticeMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: named in the noticeKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: named in the noticeLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: nationwideTXFlorida: named in the noticeFL

FDA distribution: “U.S. Nationwide distribution including in the states of CA, FL, KS, LA, MO, and PA. No OUS Consignees.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Florida, Kansas, Louisiana, Missouri, Pennsylvania.

Recall timeline

FDA terminated this recall 2.2 years after the firm started it.

1. Firm started the recall: Aug 6, 202012. FDA classified it Class II: Sep 9, 202023. Published in FDA’s Enforcement Report: Sep 16, 202034. FDA terminated the recall: Oct 7, 2022420202022
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

Is there a risk of injury from these discs?

The recall is for potential inaccuracies in dental restorations, not a direct safety hazard like injury or fire.

Similar recalls

Latest medical device recalls

Keep exploring

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2943-2020 (August 6, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2943-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA