| Date Initiated by Firm |
April 05, 2024 |
| Date Posted |
April 30, 2024 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-1703-2024 |
| Recall Event ID |
94401 |
| 510(K)Number |
K051705
|
| Product Classification |
Powder, porcelain - Product Code EIH
|
| Product |
IPS e.max ZirCAD CER/in. Prime BL1 C17/3- A zirconium oxide block for the fabrication of
fixed, full-contour restorations in anterior and posterior teeth.
Article Number: 758434
|
| Code Information |
UDI-DI:
(01)07615208438703 (11)231117 (10)Z063MW (241)758434
(01)07615208438703 (11)231214 (10)Z067JD(241)758434
Lot Numbers: Z063MW, Z067JD
|
Recalling Firm/
Manufacturer |
IVOCLAR VIVADENT AG
BEDERSRASSE
LIECHTSTEIN Germany
|
Manufacturer Reason
for Recall |
Defective blocks may show cracks after sintering
If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
|
FDA Determined
Cause 2 |
Under Investigation by firm |
| Action |
Ivokar issued Urgent Use and Safety Notice (03-2024-003-R) Letter to Distributors/End users via Fed'X or Email on 4/05/24. Letter states reason for recall, heath risk and action to take:
1. Identification of the IPS e.max ZirCAD Prime CEREC/inLab, C17 Block batches
affected by the recall.
2. Separate the blocks so that they can no longer be used for the fabrication of dental
restorations.
3. Contact the Customer Service of the distributor from whom you purchased the
affected IPS e.max ZirCAD Prime CEREC/inLab, C17 Blocks to announce the return
of the devices.
Please note on the delivery bill Recall Ivoclar Vivadent AG (03-2024-003-R) .
Your distributor will collect the devices affected by the recall and return them to
Ivoclar.
4. In addition, please complete the Customer Reply Form in the attachment and send
the completed form to vigilance.li@ivoclar.com.
1. Queries regarding the Risk Minimising Safety Measures described in this Field
Safety Notice should be addressed to:
Responsible Department at Manufacturer of the Devices:
Global Vigilance
Email vigilance.li@ivoclar.com
Postal Address Ivoclar Vivadent AG
Customer Care
Global Vigilance
Bendererstrasse 2
FL-9494 Schaan
Liechtenstein
All queries by email will be answered within one working day (24 hours).
If you have given the products to a third party, please forward a copy of this
information or inform Global Vigilance via vigilance.li@ivoclar.com.
2. Queries regarding replacement for the IPS e.max ZirCAD Prime CEREC/inLab, C17
Block affected by this field safety notice please contact the customer service of
your distributor of the Ivoclar Vivadent AG device. We will arrange all refunds with
your responsible distributor.
Your distributor will check the availability of the replacement material with Ivoclar
Partner Support and let you know when the replacement material will be shipped
to you.
|
| Quantity in Commerce |
2286 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
| 510(K) Database |
510(K)s with Product Code = EIH and Original Applicant = IVOCLAR VIVADENT, INC.
|
