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U.S. Department of Health and Human Services

Class 2 Device Recall Zenostar MT Color D3

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 Class 2 Device Recall Zenostar MT Color D3see related information
Date Initiated by FirmMay 27, 2016
Create DateOctober 04, 2016
Recall Status1 Terminated 3 on June 14, 2018
Recall NumberZ-0035-2017
Recall Event ID 74320
510(K)NumberK152118 
Product Classification Powder, porcelain - Product Code EIH
ProductZenostar MT Color D3 60ml, art. no. 681064. Product Usage: For coloring dental porcelain
Code Information Lot No: U38639, exp date: Sep 15 2017  
Recalling Firm/
Manufacturer		 Ivoclar Vivadent, Inc.
175 Pineview Dr
Amherst NY 14228-2231
For Additional Information ContactDonna Marie Hartnett
716-691-0010
Manufacturer 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.
FDA Determined
Cause 2		Process design
ActionWieland 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.
Quantity in Commerce18 units
DistributionUS 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = EIH
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