The Recall Desk
ModerateFDA (Devices)·Z-0025-2017·Announced 2016-10-12

Ivoclar Vivadent Recalls Zenostar MT Color A4 Dental Porcelain Liquid

Ivoclar Vivadent is recalling 11 units of Zenostar MT Color A4 dental porcelain 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, but the hazard is limited to potential skin irritation from packaging leaks without reports of serious injury or hospitalization, fitting the Moderate criteria for low-risk contamination or minor defects.

Plain-English summary

Ivoclar Vivadent, Inc. is recalling 11 units of Zenostar MT Color A4 60ml dental porcelain liquid, article number 681054. The affected product is identified by Lot No. U38746 and has an expiration date of September 15, 2017.

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 stop using the affected product and contact the recalling firm for instructions on return or disposal.

The recalled product

Product
Zenostar MT Color A4 60ml, art. no. 681054. Product Usage: For coloring dental porcelain
Manufacturer
Ivoclar Vivadent, Inc.
Category
Medical Device — Dental Materials
Hazard
Affected units
11

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: U38746
  • 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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