Recall Z-1839-2020 ยท EIH Powder, Porcelain
Ivoclar Vivadent AG
Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A3 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: 686195
| Date | Apr 13, 2020 |
| Status | Terminated |
| Reason | Restorations crack during the sintering process. |
| Root cause | 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 |
| Quantity | 639 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051705 | IPS E.MAX CAD/IPS E.MAX ZIRCAD Ivoclar Vivadent, Inc., Oct 14, 2005 |