Recall Z-1703-2024 ยท EIH Powder, Porcelain
IVOCLAR VIVADENT AG
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
| Date | Apr 30, 2024 (initiated Apr 5, 2024) |
| Status | Open, Classified |
| Reason | Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration |
| Root cause | 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 |
| Quantity | 2286 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 |