IVOCLAR VIVADENT AG: Medical Device Recall in 2024 - (Recall #: Z-1705-2024)

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 A2 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758438

Product Classification:

Class II

Date Initiated: April 5, 2024

Date Posted: May 8, 2024

Recall Number: Z-1705-2024

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: 11330 units

Code Information:

UDI-DI: (01)07615208438666 (11)231117 (10)Z063MX (241)758438; (01)07615208438666 (11)231214 (10)Z067JH (241)758438; (01)07615208438666 (11)240105 (10)Z06B6Y (241)758438; (01)07615208438666 (11)240118 (10)Z06D4N (241)758438 Batch No. Z063MX, Z067JH, Z067J9, Z06B6Y, Z06D4N

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated