Date Initiated by Firm |
April 13, 2020 |
Create Date |
May 01, 2020 |
Recall Status1 |
Terminated 3 on January 22, 2021 |
Recall Number |
Z-1837-2020 |
Recall Event ID |
85450 |
510(K)Number |
K051705
|
Product Classification |
Powder, porcelain - Product Code EIH
|
Product |
Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A1 C17/5 -ceramic for dental use, intended for IPS e.max ZirCAD presintered yttrium oxide-stabilized zirconium oxide blocks for the CAD/CAM technology Product Number: 686193
|
Code Information |
Lot Number: Y48711 |
Recalling Firm/ Manufacturer |
Ivoclar Vivadent AG Benderer Strasse 2 Schaan Liechtenstein
|
Manufacturer Reason for Recall |
Restorations crack during the sintering process.
|
FDA Determined Cause 2 |
Process control |
Action |
Ivoclar Vivadent issued notification via email to distributors on 4/13/20 via email and email and priority mail to Dentists, labs on by 4/20/20. Letter states reason for recall, health risk and action to take: Actions to be taken:
1. Check your stock and immediately segregate any material marked with the affected lot numbers.
2. Discard product.
3. Complete, sign and return the attached acknowledgement form and email to
Scott.Buchheit@pattersondental.com.
4. Credit will be issued for all returned acknowledgment forms
Questions contact Ivoclar Vivadent Customer Service at 800-533-6825 or your Patterson representative. |
Quantity in Commerce |
9 units |
Distribution |
US Nationwide distribution. |
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 = EIH and Original Applicant = IVOCLAR VIVADENT, INC.
|