Date Initiated by Firm |
August 03, 2017 |
Create Date |
February 21, 2018 |
Recall Status1 |
Terminated 3 on August 28, 2018 |
Recall Number |
Z-0665-2018 |
Recall Event ID |
79064 |
510(K)Number |
K884588
|
Product Classification |
Material, tooth shade, resin - Product Code EBF
|
Product |
Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501 |
Code Information |
Batch: V35109 Exp. date: 01.10.2020; Batch: V40817 Exp. date: 13.11.2020; Batch: V48597 Exp. date: 30.12.2020; Batch: V48938 Exp. date: 31.12.2020 Batch: W12251 Exp. date: 31.03.2021 |
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 |
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 |
2,153 units |
Distribution |
US and Canada |
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 = EBF and Original Applicant = WILLIAMS DENTAL CO., INC.
|