The Recall Desk
ModerateFDA (Devices)·Z-0026-2017·Announced 2016-10-12

Ivoclar Vivadent Recalls Zenostar MT Color B1 Dental Porcelain Coloring Liquid

Ivoclar Vivadent is recalling 43 units of Zenostar MT Color B1 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 potential skin irritation from packaging leaks, which aligns with the 'Moderate' severity criteria for low-risk contamination or minor issues without reported serious injury.

Plain-English summary

Ivoclar Vivadent, Inc. is recalling 43 units of Zenostar MT Color B1 60ml dental porcelain coloring liquid (article no. 681055). The affected lots are U49851 (exp. Nov 2, 2017), U49838 (exp. Nov 2, 2017), and U39117 (exp. Sep 17, 2017). The product was 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.

The recall is being conducted 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.

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 B1 60ml, art. no. 681055. Product Usage: For coloring dental porcelain
Manufacturer
Ivoclar Vivadent, Inc.
Category
Medical Device — Dental Materials
Hazard
Affected units
43

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 (5)

  • Lot No: U49851
  • exp date: Nov 2 2017
  • U49838
  • and U39117
  • Sep 17 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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Same manufacturer · Ivoclar Vivadent, Inc.

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