CLASS II Device recall · Reported 16 Sep 2020 · FDA Enforcement Report

Luminesse Zirconia Discs, Zirconia HT Disc 98x20mm A1 recalled

Talladium is recalling Luminesse Zirconia Discs, Zirconia HT Disc 98x20mm A1, Shaded Zirconia Blend 2.0 50# A1, distributed nationwide in the US. The recall was initiated on 6 Aug 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number.: 1AZG

Quantity recalled39 pieces

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2943-2020
FDA event ID: 86227
Recalling firm: Talladium, Valencia, CA
Classification: Class II
Status: Terminated
Recall initiated: 6 Aug 2020
FDA classified: 9 Sep 2020
Reported: 16 Sep 2020
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Foreign Material
Device type: Dental Devices

Timeline

6 Aug 2020	Recall initiated by company
9 Sep 2020	Classified by FDA	+34 days
16 Sep 2020	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

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.

Where it was distributed

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

Nationwide California Florida Kansas Louisiana Missouri Pennsylvania

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot Number.: 1AZG

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Talladium

All 2

Reported	Class	Recall	Company	Reason	Where
9 Dec 2020Device	CLASS III	Luminesse ML PMMA, 98x20mm recalled by Talladium	Talladium	Labeling Errors	Nationwide

Other Dental Devices recalls

All 426

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Device	CLASS II	Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm recalled	Henry Schein	Packaging Defects	Nationwide
19 Aug 2026Device	CLASS II	GM Helix Implant, Endosseous Dental Implant Article No. recalled	Straumann USA	Packaging Defects	Nationwide
15 Jul 2026Device	CLASS II	KL Owen Custom Orthodontic Solution recalled by Klowen Braces	Klowen Braces	Device Malfunction	Nationwide
6 May 2026Device	CLASS II	Straumann n!ce PMMA Full-arch Restoration recalled	Straumann USA	Other	8 states
6 May 2026Device	CLASS II	Straumann n!ce Zr, HT, Full-arch Restoration recalled	Straumann USA	Other	8 states