Reported May 8, 2024 · Ongoing
IPS e.max ZirCAD CER/in. Prime A3 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour…
Ivoclar Vivadent Ag
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: IVOCLAR VIVADENT AG · BEDERSRASSE · LIECHTSTEIN · N/A
Is this the product you have?
- IPS e.max ZirCAD CER/in. Prime A3 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior
- and posterior teeth Article Number758439
- Lot codes and dates
7 of 7 products
Products covered by this recall # Barcodes Product as published 1 07615208438659(01)07615208438659 (11)231117 (10)Z063MT (241)758439 2 07615208438659(01)07615208438659 (11)231214 (10)Z067JF (241)758439 3 07615208438659(01)07615208438659 (11)231214 (10)Z067JC (241)758439 4 07615208438659(01)07615208438659 (11)231214 (10)Z067JG (241)758439 5 07615208438659(01)07615208438659 (11)231214 (10)Z067JB (241)758439 6 07615208438659(01)07615208438659 (11)240105 (10)Z06B6Z (241)758439 7 07615208438659(01)07615208438659 (11)240112 (10)Z06CBG (241)758439 Batch No. Z063MT, Z067JF, Z067JC, Z067JG, Z067JB, Z06B6Z, Z06CBG - Amount recalled
- 12525 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
Why it was recalled
Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
This product could cause temporary or reversible health problems — stop using it.
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