IPS e.max ZirCAD CER/in. Prime C2 C17/5- A zirconium oxide block for the fabrication of fixed, full-contour restoration
Summary
The FDA issued a Class II for IPS e.max ZirCAD CER/in. Prime C2 C17/5- A zirconium oxide block for the fabrica by IVOCLAR VIVADENT AG. Reason: Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration.
Details
Source
Device Recall
External ID
Z-1708-2024
Action Date
2024-05-08
Status
Ongoing
Category
device
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
Lot/Code Info: UDI-DI: (01)07615208438611 (11)231130 (10)Z065M1 (241)758443 Batch No.: Z065M1
Quantity Affected: 2472 units
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
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-04-05
Company
LIECHTSTEIN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 175 device recalls issued in the same week, part of 403 device-related FDA actions this month.
IVOCLAR VIVADENT AG has 7 FDA actions in our database, including 6 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (IVOCLAR VIVADENT AG) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does IVOCLAR VIVADENT AG have FDA actions?
IVOCLAR VIVADENT AG has 7 FDA actions in our database, including 6 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1708-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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