FDAClass IIOctober 12, 2016

Zenostar MT Color C2 recall

Zenostar MT Color C2 60ml art. no. 681060. Product Usage: For coloring dental porcelain

Why was Zenostar MT Color C2 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot No: U44095, exp date: Oct 19 2017 and U38600, exp date: Sep 15 2017

Product
Zenostar MT Color C2 60ml art. no. 681060. Product Usage: For coloring dental porcelain
Recalling firm
Ivoclar Vivadent, Inc.
Quantity
19 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.
Recall date
October 12, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls