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Terminated

Zenostar MT Color D2 60ml, art. no. 681063. Product Usage: For coloring dental porcelain

FDA Recall Z-0034-2017 · Posted None

Recalling FirmIvoclar Vivadent, Inc.
Recall StatusTerminated
Product CodeEIH
Date Initiated2016-05-27
Date Terminated2018-06-14
Product Quantity40 units

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.

Firm Action

Wieland sent an Urgent Medical Device Recall Notification letters dated May 27, 2016, and Response Forms to their customers via courier service to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to Segregate any affected materials immediately. Customers were asked to complete the attached Acknowledgment form and return it to Ivoclar Vivadent, Inc. by mail, fax or email as indicated on the form. For questions contact Ivoclar Vivadent Technical Customer Service at 800-533-6825.

Root Cause

Process design

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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