Ivoclar Vivadent, Inc. recalls Zenostar MT Color D3 60ml, art. no. 681064. Product Usage: For coloring dental porcelain

Recall date

May 27, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0035-2017

FDA classification

Class II

Brand / firm

Ivoclar Vivadent, Inc.

Sold / distributed

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.

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Zenostar MT Color D3 60ml, art. no. 681064. Product Usage: For coloring dental porcelain