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U.S. Department of Health and Human Services

Class 2 Device Recall Virtual XD

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  Class 2 Device Recall Virtual XD see related information
Date Initiated by Firm November 09, 2016
Create Date December 07, 2016
Recall Status1 Terminated 3 on June 18, 2018
Recall Number Z-0718-2017
Recall Event ID 75620
510(K)Number K083739  
Product Classification Material, impression - Product Code ELW
Product Virtual XD Refill Light Body Regular Set Wash Material, 2X50 ml, REF #/Product Code 646462, Rx ONLY --

Product Usage:
Dental impression material
Code Information Lot No./Expiration Date: UL2221/July 28, 2017; TL4056/Nov 28, 2016
Recalling Firm/
Manufacturer		 Ivoclar Vivadent, Inc.
175 Pineview Dr
Amherst NY 14228-2231
For Additional Information Contact Ivoclar Vivadent Customer Service
800-533-6825
Manufacturer Reason
for Recall		 The firm received complaints claiming the dental material failed to set up. As the dental material ages, the set time may increase.
FDA Determined
Cause 2		 Under Investigation by firm
Action Ivoclar Vivadent sent and URGENT - MEDICAL DEVICE RECALL Letters (dated 11/07/2016) and Recall Response Forms to customers via Certified Mail-Return Receipt Requested. The letter identified the affected product, problem and actions to be taken. Customers were advised to return all affected products in stock. For questions contact Ivoclar Vivadent Customer Service at 800-533-6825.
Quantity in Commerce US: 1867 units, Canada: 465 units
Distribution Worldwide Distribution - US Nationwide and the countries of Canada and Australia
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 = ELW and Original Applicant = ZHERMACK S.P.A.
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