The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0018-2017·Announced 2016-10-12

Ivoclar Vivadent Recalls Zenostar MT Color Impulse Brown Dental Porcelain

Ivoclar Vivadent is recalling 11 units of Zenostar MT Color Impulse brown dental porcelain due to potential 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 potential skin irritation from packaging leaks, which fits the criteria for moderate severity without reports of serious injury.

Plain-English summary

Ivoclar Vivadent, Inc. is recalling 11 units of Zenostar MT Color Impulse brown, article number 681169, used for coloring dental porcelain. The recall involves specific lots with expiration dates of September 20, 2017, and October 19, 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 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. Users should discontinue use of the affected lots and contact the manufacturer for further instructions.

The recalled product

Product
Zenostar MT Color Impulse brown, art. no. 681169 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 (4)

  • Lot No: U44405
  • expiration date: Oct 19 2017
  • U39262
  • expiration date: Sep 20 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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