FDA Medical Device Recalls (openFDA)
Ivoclar Vivadent AG: 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
- Recall number
- Z-1838-2020
- Recalling firm
- Ivoclar Vivadent AG
- Product
- 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
- Status
- Terminated
- Initiated
- 2020-04-13
- Posted
- not on file
- Terminated
- 2021-01-22
- Reason
- Restorations crack during the sintering process.
- Root cause
- Process control
- 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 Scott.Buchheit@pattersondental.com. 4. Credit will be issued for all returned acknowledgment forms Questions contact Ivoclar Vivadent Customer Service at 800-533-6825 or your Patterson representative.
- Quantity
- 332
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- Lot Numbers: Y47472, Z000V0
- 510(k) numbers
- ["K051705"]
- PMA numbers
- not on file
- Product code
- EIH
- Firm FEI
- 3002808636
- Firm city
- Schaan
- Firm state
- not on file
- Firm country
- Liechtenstein
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28