The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0020-2017·Announced 2016-10-12

Ivoclar Vivadent Recalls Zenostar MT Color Impulse Violet Due to Packaging Leaks

Ivoclar Vivadent is recalling 25 units of Zenostar MT Color Impulse violet dental porcelain coloring due to packaging leaks that may cause skin irritation.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 is limited to skin irritation from potential packaging leaks, which fits the criteria for moderate severity involving low-risk contamination or minor issues.

Plain-English summary

Ivoclar Vivadent, Inc. is recalling 25 units of Zenostar MT Color Impulse violet, article number 681166, used for coloring dental porcelain. The recall affects specific lots with expiration dates in September and October 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 affected products 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 affected units and contact the recalling firm for instructions on return or disposal.

The recalled product

Product
Zenostar MT Color Impulse violet, art. no. 681166 Product Usage: For coloring dental porcelain
Manufacturer
Ivoclar Vivadent, Inc.
Category
Medical Device — Dental Materials
Hazard
Affected units
25

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 (6)

  • Lot No: U49960
  • Exp. date: Nov 2 2017
  • U44396
  • exp. date: Oct 19 2017
  • and U38897
  • 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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