The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0027-2017·Announced 2016-10-12

Ivoclar Vivadent Recalls Zenostar MT Color B2 Dental Porcelain Coloring Liquid

Ivoclar Vivadent is recalling 15 units of Zenostar MT Color B2 dental porcelain coloring liquid 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 involves potential skin irritation from packaging leaks without reports of serious injury or hospitalization, fitting the Moderate severity criteria for low-risk contamination or minor defects.

Plain-English summary

Ivoclar Vivadent, Inc. is recalling 15 units of Zenostar MT Color B2 60ml dental porcelain coloring liquid (article no. 681056). The affected product is identified by Lot No. U39398 and has an expiration date of September 21, 2017.

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 product was distributed nationwide in the United States to the following states: 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 replacement.

The recalled product

Product
Zenostar MT Color B2 60ml, art. no. 681056. Product Usage: For coloring dental porcelain
Manufacturer
Ivoclar Vivadent, Inc.
Category
Medical Device — Dental Materials
Hazard
Affected units
15

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: U39398
  • exp date: Sep 21 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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