The Recall Desk
ModerateFDA (Devices)·Z-0036-2017·Announced 2016-10-12

Ivoclar Vivadent Recalls Zenostar MT Color D4 Dental Porcelain Coloring Liquid

Ivoclar Vivadent is recalling 9 units of Zenostar MT Color D4 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, but the hazard is limited to skin irritation from potential leaks, which aligns with the criteria for moderate severity involving low-risk contamination or minor issues without reported serious injury.

Plain-English summary

Ivoclar Vivadent, Inc. is recalling 9 units of Zenostar MT Color D4 60ml dental porcelain coloring liquid (article no. 681065). The recall involves Lot No. U38680 with an expiration date of September 15, 2017. The product is used for coloring dental porcelain.

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, and direct contact with this liquid may lead to skin irritation.

The affected units were distributed nationwide 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. Consumers and dental professionals should stop using the product and contact Ivoclar Vivadent for further instructions.

The recalled product

Product
Zenostar MT Color D4 60ml, art. no. 681065. Product Usage: For coloring dental porcelain
Manufacturer
Ivoclar Vivadent, Inc.
Category
Medical Device — Dental Materials
Hazard
Affected units
9

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: U38680
  • 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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