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U.S. Department of Health and Human Services

Class 3 Device Recall Heliomolar

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 Class 3 Device Recall Heliomolarsee related information
Date Initiated by FirmAugust 03, 2017
Create DateFebruary 21, 2018
Recall Status1 Terminated 3 on August 28, 2018
Recall NumberZ-0667-2018
Recall Event ID 79064
510(K)NumberK884588 
Product Classification Material, tooth shade, resin - Product Code EBF
ProductHeliomolar Refill 20x0.25g 210/A3, Product code 541503AN, Catalog number 541503
Code Information Batch: V37905, Exp. date: 21.10.2020; Batch: V45006, Exp. date: 04.12.2020; Batch: V49583, Exp. date: 12.01.2021; Batch: W04412, Exp. date: 20.02.2021; Batch: W13322, Exp. date: 07.04.2021
Recalling Firm/
Manufacturer		 Ivoclar Vivadent, Inc.
175 Pineview Dr
Amherst NY 14228-2231
For Additional Information Contact
716-691-0010
Manufacturer Reason
for Recall		Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing and contouring.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionThe firm sent letters to consignees on August 3, 2017 instructing them to segregate the recalled product and arrange for a replacement of stock.
Quantity in Commerce1,244 units
DistributionUS and Canada
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 = EBF
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