| Class 3 Device Recall Heliomolar | |
Date Initiated by Firm | August 03, 2017 |
Create Date | February 21, 2018 |
Recall Status1 |
Terminated 3 on August 28, 2018 |
Recall Number | Z-0666-2018 |
Recall Event ID |
79064 |
510(K)Number | K884588 |
Product Classification |
Material, tooth shade, resin - Product Code EBF
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Product | Heliomolar Refill 20x0.25g 140/A2, Product code 541502AN, Catalog number 541502 |
Code Information |
Batch: V37176, Exp. date: 15.10.2020; Batch: V40818, Exp. date: 13.11.2020; Batch: V45145, Exp. date: 05.12.2020; Batch: V51367, Exp. date: 22.01.2021; Batch: W00520, Exp. date: 29.01.2021; Batch: W01514, Exp. date: 04.02.2021; Batch: W07036, Exp. date: 05.03.2021; Batch: W13323, Exp. date: 07.04.2021 |
Recalling Firm/ Manufacturer |
Ivoclar Vivadent, Inc. 175 Pineview Dr Amherst NY 14228-2231
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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 |
Action | The 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 Commerce | 3,255 units |
Distribution | US and Canada |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = EBF
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