| Date Initiated by Firm | August 03, 2017 |
|---|
| Create Date | February 21, 2018 |
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| Recall Status1 |
Terminated 3 on August 28, 2018 |
| Recall Number | Z-0668-2018 |
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| Recall Event ID |
79064 |
| 510(K)Number | K884588 |
|---|
| Product Classification |
Material, tooth shade, resin - Product Code EBF
|
| Product | Heliomolar Refill 20x0.25g 110T, Product code 550559AN, Catalog number 550559 |
|---|
| Code Information |
Batch: W12503, Exp. date: 01.04.2021 |
Recalling Firm/
Manufacturer |
Ivoclar Vivadent, Inc.
175 Pineview Dr
Amherst NY 14228-2231
|
| For Additional Information Contact |
716-691-0010 |
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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. |
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FDA Determined
Cause 2 | Nonconforming Material/Component |
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| 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. |
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| Quantity in Commerce | 2 units |
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| Distribution | US and Canada |
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| 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.
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| 510(K) Database | 510(K)s with Product Code = EBF
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