Ivoclar Vivadent recalls IPS e.max ZirCAD CER/in. Prime B1 C17/5 zirconium oxide blocks that may crack after sintering, risking restoration fractures in patients.
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 B1 C17/5 zirconium oxide blocks that may develop cracks after sintering. If these cracks are not noticed, the restorations could fracture in the patient's mouth, requiring additional dental work.
The blocks may develop cracks after sintering. If these cracks are not detected, the dental restorations could fracture inside the patient's mouth, leading to the need for additional dental procedures.
Dentists and dental labs using the IPS e.max ZirCAD CER/in. Prime B1 C17/5 zirconium oxide blocks for dental restorations are affected. Patients with restorations made from these blocks are at risk if cracks develop.
Check for the article number 758441 or UDI-DI codes (01)07615208438635 (11)231130 (10)Z065M0 (241)758441 and (01)07615208438635 (11)240112 (10)Z06CBH. The batch numbers Z065M0 and Z06CBH are also indicators of the recalled blocks.
Inspect the blocks for cracks after sintering, as undetected cracks may cause restorations to fracture in the patient's mouth.
The recall does not specify a stop-use instruction; dentists and labs should check for cracks before use.
If cracks are noticed, the restorations may need to be replaced, but the recall does not provide specific steps for this.
Look for the article number 758441 or UDI-DI codes (01)07615208438635 (11)231130 (10)Z065M0 (241)758441 and (01)07615208438635 (11)240112 (10)Z06CBH with batch numbers Z065M0 or Z06CBH.
We’ve drafted a message you can send Ivoclar Vivadent to request your refund or repair — edit it as you like.
Subject: Recall Z-1707-2024 — Ivoclar Vivadent Ivoclar Vivadent Hello, I own a Ivoclar Vivadent that is covered by recall Z-1707-2024 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.
