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Terminated

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

FDA Recall Z-1838-2020 · Posted None

Recalling FirmIvoclar Vivadent AG
Recall StatusTerminated
Product CodeEIH
Date Initiated2020-04-13
Date Terminated2021-01-22
Product Quantity332

Reason for Recall

Restorations crack during the sintering process.

Firm Action

Ivoclar Vivadent issued notification via email to distributors on 4/13/20 via email and email and priority mail to Dentists, labs on by 4/20/20. Letter states reason for recall, health risk and action to take: Actions to be taken: 1. Check your stock and immediately segregate any material marked with the affected lot numbers. 2. Discard product. 3. Complete, sign and return the attached acknowledgement form and email to [email protected]. 4. Credit will be issued for all returned acknowledgment forms Questions contact Ivoclar Vivadent Customer Service at 800-533-6825 or your Patterson representative.

Root Cause

Process control

Distribution Pattern

US Nationwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K051705IPS E.MAX CAD/IPS E.MAX ZIRCADIvoclar Vivadent, Inc. · 2005-10-14

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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