The Recall Desk
ModerateFDA (Devices)·Z-0019-2017·Announced 2016-10-12

Ivoclar Vivadent Recalls Zenostar MT Color Impulse Grey Dental Porcelain

Ivoclar Vivadent is recalling 60 units of Zenostar MT Color Impulse grey dental porcelain 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 potential skin irritation from liquid leakage, which fits the criteria for moderate severity involving low-risk contamination or minor labeling/packaging issues without reported serious injury.

Plain-English summary

Ivoclar Vivadent, Inc. is recalling 60 units of Zenostar MT Color Impulse grey, art. no. 681167, a product used for coloring dental porcelain. The recall involves specific lots with expiration dates ranging from September 2017 to March 2018.

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, including 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 products and contact the recalling firm for instructions on return or disposal.

The recalled product

Product
Zenostar MT Color Impulse grey, art. no. 681167 Product Usage: For coloring dental porcelain
Manufacturer
Ivoclar Vivadent, Inc.
Category
Medical Device — Dental Materials
Hazard
Affected units
60

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 (8)

  • Lot No: U52159
  • exp date: Mar 30 2018
  • U52107
  • exp date: Nov 16 2017
  • U44397
  • exp date: Oct 19 2017
  • and U39255
  • exp 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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Same manufacturer · Ivoclar Vivadent, Inc.

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