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U.S. Department of Health and Human Services

Class 2 Device Recall Zenostar MT Color C2

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  Class 2 Device Recall Zenostar MT Color C2 see related information
Date Initiated by Firm May 27, 2016
Create Date October 04, 2016
Recall Status1 Terminated 3 on June 14, 2018
Recall Number Z-0031-2017
Recall Event ID 74320
510(K)Number K152118  
Product Classification Powder, porcelain - Product Code EIH
Product Zenostar MT Color C2 60ml art. no. 681060.

Product Usage:
For coloring dental porcelain
Code Information Lot No: U44095, exp date: Oct 19 2017 and U38600, exp date: Sep 15 2017  
Recalling Firm/
Manufacturer		 Ivoclar Vivadent, Inc.
175 Pineview Dr
Amherst NY 14228-2231
For Additional Information Contact Donna 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
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.
Quantity in Commerce 19 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.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = EIH and Original Applicant = WIELAND DENTAL + TECHNIK GMBH & CO. KG
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