IPS e.max ZirCAD CER/in. Prime BL1 C17/3- A zirconium recall
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…
Why was IPS e.max ZirCAD CER/in. Prime BL1 C17/3- A zirconium recalled?
Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: (01)07615208438703 (11)231117 (10)Z063MW (241)758434 (01)07615208438703 (11)231214 (10)Z067JD(241)758434 Lot Numbers: Z063MW, Z067JD
- 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…
- Recalling firm
- IVOCLAR VIVADENT AG
- Quantity
- 2286 units
- Distribution
- US Nationwide distribution.
- Recall date
- May 8, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)