The Recall Desk
ModerateFDA (Devices)·Z-0030-2017·Announced 2016-10-12

Ivoclar Vivadent Recalls Zenostar MT Color C1 Dental Porcelain Coloring Liquid

Ivoclar Vivadent is recalling 37 units of Zenostar MT Color C1 dental porcelain coloring liquid because packaging leaks 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 reported serious injury.

Plain-English summary

Ivoclar Vivadent, Inc. is recalling 37 units of Zenostar MT Color C1 60ml dental porcelain coloring liquid. The recall affects specific lots with expiration dates ranging from September 16, 2017, to November 11, 2017. The product was distributed nationwide in 31 states, including Alaska, California, Florida, New York, and Texas.

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. Direct contact with this liquid may lead to skin irritation.

Consumers and dental professionals who have purchased or received these specific lots should stop using the product and contact Ivoclar Vivadent, Inc. for further instructions or a return.

The recalled product

Product
Zenostar MT Color C1 60ml, art. no. 681059. Product Usage: For coloring dental porcelain
Manufacturer
Ivoclar Vivadent, Inc.
Category
Medical Device — Dental Materials
Hazard
Affected units
37

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 (7)

  • Lot No: U51611
  • exp date: Nov 11 2017
  • U50758
  • exp date: Nov 5 2017
  • U43929
  • and U38834
  • exp date: Sep 16 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 →

Related recalls

Same manufacturer · Ivoclar Vivadent, Inc.

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