The Recall Desk
ModerateFDA (Devices)·Z-0031-2017·Announced 2016-10-12

Ivoclar Vivadent Recalls Zenostar MT Color C2 Dental Porcelain Coloring Liquid

Ivoclar Vivadent is recalling 19 units of Zenostar MT Color C2 dental porcelain coloring liquid due to potential 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. The hazard is limited to potential skin irritation from packaging leaks, which aligns with the rubric for moderate severity involving low-risk contamination or minor defects without reported serious injury.

Plain-English summary

Ivoclar Vivadent, Inc. is recalling 19 units of Zenostar MT Color C2 60ml (article no. 681060), a liquid used for coloring dental porcelain. The recall involves two specific lots: U44095 (expiration date Oct 19, 2017) and U38600 (expiration date Sep 15, 2017). The product was distributed nationwide in the United States to 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 issued 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 C2 60ml art. no. 681060. Product Usage: For coloring dental porcelain
Manufacturer
Ivoclar Vivadent, Inc.
Category
Medical Device — Dental Materials
Hazard
Affected units
19

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 (3)

  • Lot No: U44095
  • exp date: Oct 19 2017 and U38600
  • 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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