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Recall Observatory FDA recall evidence

Device product

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

Z-0037-2017

May 27, 2016

Class II

Product summary

Firm
Ivoclar Vivadent, Inc.
Event
Event 74320
Status
Terminated
Classification
Class II
Quantity
5 units
Official record key
device-enforcement:Z-0037-2017

Official wording

Reason: 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.

Code information: 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

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.