PlainRecalls
FDA Devices Moderate Class II Terminated

Zenostar MT Color B3 60ml, art. no. 681057. Product Usage: For coloring dental porcelain

Reported: October 12, 2016 Initiated: May 27, 2016 #Z-0028-2017

Product Description

Zenostar MT Color B3 60ml, art. no. 681057. Product Usage: For coloring dental porcelain

Reason for Recall

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.

Details

Recalling Firm
Ivoclar Vivadent, Inc.
Units Affected
27 units
Distribution
US Nationwide Distribution 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.
Location
Amherst, NY

Frequently Asked Questions

What product was recalled?
Zenostar MT Color B3 60ml, art. no. 681057. Product Usage: For coloring dental porcelain. Recalled by Ivoclar Vivadent, Inc.. Units affected: 27 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on October 12, 2016. Severity: Moderate. Recall number: Z-0028-2017.