The Recall Desk
ModerateFDA (Devices)·Z-0037-2017·Announced 2016-10-12

Ivoclar Vivadent Recalls Zenostar MT Color Impulse Orange Dental Porcelain

Ivoclar Vivadent is recalling 5 units of Zenostar MT Color Impulse orange dental porcelain 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, and the hazard involves potential skin irritation from packaging leaks, which fits the criteria for moderate severity involving low-risk contamination or minor labeling/packaging issues.

Plain-English summary

Ivoclar Vivadent, Inc. is recalling 5 units of Zenostar MT Color Impulse orange, article number 681168. This product is used for coloring dental porcelain. The recall involves specific lots with expiration dates ranging from September 2017 to January 2018.

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, and direct contact with this liquid may lead to skin irritation.

The affected units 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 lots and contact Ivoclar Vivadent for further instructions.

The recalled product

Product
Zenostar MT Color Impulse orange, art. no. 681168. Product Usage: For coloring dental porcelain
Manufacturer
Ivoclar Vivadent, Inc.
Category
Medical Device — Dental Materials
Hazard
Affected units
5

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 (10)

  • Lot No: U44402
  • expiration date: Oct 19 2017
  • V01767
  • expiration date: Jan 18 2018
  • U52968
  • expiration date: Jan 18 2018
  • U53010
  • expiration date: Nov 16 2017
  • and U38982
  • expiration date: Sep 17 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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Same manufacturer · Ivoclar Vivadent, Inc.

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