The Recall Desk
ModerateFDA (Devices)·Z-0035-2017·Announced 2016-10-12

Ivoclar Vivadent Recalls Zenostar MT Color D3 Dental Porcelain Coloring Liquid

Ivoclar Vivadent is recalling 18 units of Zenostar MT Color D3 dental porcelain coloring liquid due to packaging leaks that may cause skin irritation.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves potential skin irritation from packaging leaks, which aligns with the criteria for moderate severity involving low-risk contamination or minor labeling/packaging issues.

Plain-English summary

Ivoclar Vivadent, Inc. is recalling 18 units of Zenostar MT Color D3 60ml dental porcelain coloring liquid (article no. 681064). The affected lot number is U38639, with an expiration date of September 15, 2017. The product was distributed nationwide in the United States, specifically in the states of AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.

The recall was initiated because the primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently. Direct contact with this liquid may lead to skin irritation.

Consumers and dental professionals should stop using the affected product and contact Ivoclar Vivadent, Inc. for further instructions or a refund.

The recalled product

Product
Zenostar MT Color D3 60ml, art. no. 681064. Product Usage: For coloring dental porcelain
Manufacturer
Ivoclar Vivadent, Inc.
Category
Medical Device — Dental Materials
Hazard
Affected units
18

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot No: U38639
  • exp date: Sep 15 2017

Distribution

Distributed nationwide across the United States.

The notice also names 31 states specifically:

Part of a larger recall action

This product is one of 21 recalled by Ivoclar Vivadent, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 21 products in this recall →

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