The Recall Desk
ModerateFDA (Devices)·Z-0024-2017·Announced 2016-10-12

Ivoclar Vivadent Recalls Zenostar MT Color A3.5 Dental Porcelain Coloring Liquid

Ivoclar Vivadent is recalling 17 units of Zenostar MT Color A3.5 dental porcelain coloring liquid 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, but the hazard is limited to potential skin irritation from packaging leaks, which aligns with the 'Moderate' criteria for low-risk contamination or minor issues without reports of serious injury.

Plain-English summary

Ivoclar Vivadent, Inc. is recalling 17 units of Zenostar MT Color A3.5 60ml dental porcelain coloring liquid. The affected lots are U49659 (exp. Nov 2, 2017), U43928 (exp. Oct 19, 2017), and U38672 (exp. Sep 15, 2017). The product is used for coloring dental porcelain.

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 product was 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. Users should check their inventory for the specific lot numbers and expiration dates listed above. If the product is found, it should be returned to the supplier or disposed of according to local regulations to prevent accidental contact.

The recalled product

Product
Zenostar MT Color A3.5 60ml, art. no. 681053. Product Usage: For coloring dental porcelain
Manufacturer
Ivoclar Vivadent, Inc.
Category
Medical Device — Dental Materials
Hazard
Affected units
17

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: U49659
  • exp date: Nov 2 2017
  • U43928
  • exp date: Oct 19 2017
  • and U38672
  • exp date: Sep 15 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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