Medical device recalls Moderate risk

Ivoclar Vivadent AG recalls Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A2 C17/5 - ceramic for dental use,intended for IPS e.max ZirCAD presinte…

Recall date
April 13, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1838-2020
FDA classification
Class II
Brand / firm
Ivoclar Vivadent AG
Sold / distributed
US Nationwide distribution.

Why it was recalled

Restorations crack during the sintering process.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A2 C17/5 - ceramic for dental use,intended for IPS e.max ZirCAD presintered yttrium oxide-stabilized zirconium oxide blocks for the CAD/ CAM technology Product Number: 686194

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