IVOCLAR VIVADENT AG: Medical Device Recall in 2024 - (Recall #: Z-1707-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

IPS e.max ZirCAD CER/in. Prime B1 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758441

Product Classification:

Class II

Date Initiated: April 5, 2024

Date Posted: May 8, 2024

Recall Number: Z-1707-2024

Event ID: 94401

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

Status: Ongoing

Product Quantity: 4080 units

Code Information:

UDI-DI: (01)07615208438635 (11)231130 (10)Z065M0 (241)758441; (01)07615208438635 (11)240112 (10)Z06CBH (241)758441 Batch No. Z065M0, Z06CBH

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated