Medical Device Recall: Z-0019-2017

FDA Recalls dataset · Firm: Ivoclar Vivadent, Inc. · Status: Terminated

Recall Action Class: N/A Date Initiated: 2016-05-27 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0019-2017.

Recall Res Number
Z-0019-2017
Recalling Firm / Manufacturer
Ivoclar Vivadent, Inc.
FEI Number
1316092
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2016-05-27
Date Posted
N/A
Date Terminated
2018-06-14
Product Code
EIH
Event Number
74320
Product Quantity
60 units
Product Description Zenostar MT Color Impulse grey, art. no. 681167 Product Usage: For coloring dental porcelain
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.
Action Details 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.
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.
Code Information / Serial Numbers Lot No: U52159, exp date: Mar 30 2018; U52107, exp date: Nov 16 2017; U44397, exp date: Oct 19 2017; and U39255, exp date: Sep 20 2017

Related Establishments / Registrations

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