IVOCLAR VIVADENT AG: Medical Device Recall in 2024 - (Recall #: Z-1708-2024)

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 C2 C17/5- A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758443

Product Classification:

Class II

Date Initiated: April 5, 2024

Date Posted: May 8, 2024

Recall Number: Z-1708-2024

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: 2472 units

Code Information:

UDI-DI: (01)07615208438611 (11)231130 (10)Z065M1 (241)758443 Batch No.: Z065M1

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated