Ivoclar Vivadent recalls IPS e.max ZirCAD CER/in. Prime C2 C17/5- A zirconium oxide blocks that may crack after sintering, potentially causing restorations to fracture in the mouth.
Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
Ivoclar Vivadent is recalling IPS e.max ZirCAD CER/in. Prime C2 C17/5- A zirconium oxide blocks that may crack after sintering. If cracks are unnoticed, restorations could fracture in the patient's mouth and require replacement.
The blocks may develop cracks after sintering. If these cracks are not detected, the dental restorations could fracture inside the patient's mouth, requiring additional dental work.
Dentists and dental labs that use these blocks for making dental restorations are affected. Patients with recent restorations using these blocks are at risk if cracks cause fractures.
Check for the article number 758443 or UDI-DI code (01)07615208438611 (11)231130 (10)Z065M1 (241)758443 on the block. These blocks were sold for making dental restorations.
Inspect the block for cracks after sintering, as undetected cracks can cause restorations to fracture in the mouth.
The recall does not specify a stop-use instruction; dentists should check for cracks before continuing use.
If cracks are noticed, the block should not be used for dental restorations as it may cause fractures in the patient's mouth.
Look for the article number 758443 or UDI-DI code (01)07615208438611 (11)231130 (10)Z065M1 (241)758443 on the block.
We’ve drafted a message you can send Ivoclar Vivadent to request your refund or repair — edit it as you like.
Subject: Recall Z-1708-2024 — Ivoclar Vivadent Ivoclar Vivadent Hello, I own a Ivoclar Vivadent that is covered by recall Z-1708-2024 from Ivoclar Vivadent. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
