FDAClass IIOctober 12, 2016

Zenostar MT Color Impulse orange recall

Zenostar MT Color Impulse orange, art. no. 681168. Product Usage: For coloring dental porcelain

Why was Zenostar MT Color Impulse orange 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: U44402, expiration date: Oct 19 2017; V01767, expiration date: Jan 18 2018; U52968, expiration date: Jan 18 2018; U53010, expiration date: Nov 16 2017; and U38982, expiration date: Sep 17 2017

Product
Zenostar MT Color Impulse orange, art. no. 681168. Product Usage: For coloring dental porcelain
Recalling firm
Ivoclar Vivadent, Inc.
Quantity
5 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