The Recall Desk
ModerateFDA (Devices)·Z-0029-2017·Announced 2016-10-12

Ivoclar Vivadent Recalls Zenostar MT Color B4 Dental Porcelain Liquid

Ivoclar Vivadent is recalling 7 units of Zenostar MT Color B4 dental porcelain 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 skin irritation from potential leaks, which fits the criteria for moderate severity without reports of hospitalization or severe injury.

Plain-English summary

Ivoclar Vivadent, Inc. is recalling 7 units of Zenostar MT Color B4 60ml dental porcelain liquid, article number 681058. The affected lot number is U38887, with an expiration date of September 16, 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 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. Consumers and dental professionals should check their inventory for this specific lot number and stop using the product if it matches the recalled description.

The recalled product

Product
Zenostar MT Color B4 60ml, art. no. 681058. Product Usage: For coloring dental porcelain
Manufacturer
Ivoclar Vivadent, Inc.
Category
Medical Device — Dental Materials
Hazard
Affected units
7

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: U38887
  • exp date: Sep 16 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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