🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: April 5, 2024 IVOCLAR VIVADENT AG Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI-DI: (01)07615208438703 (11)231117 (10)Z063MW (241)758434 (01)07615208438703 (11)231214 (10)Z067JD(241)758434 Lot Numbers: Z063MW, Z067JD
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
IVOCLAR VIVADENT AG
Reason for Recall:
Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

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

Product Codes/Lot Numbers:

UDI-DI: (01)07615208438703 (11)231117 (10)Z063MW (241)758434 (01)07615208438703 (11)231214 (10)Z067JD(241)758434 Lot Numbers: Z063MW, Z067JD

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1703-2024

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