FDA Medical Device Recalls (openFDA)
Ivoclar Vivadent, Inc.: Virtual XD Test Pack Heavy/Light Fast Set, 2 x 50 ml, REF #/Product Code 646469, Rx ONLY -- Product Usage: Dental impression material
- Recall number
- Z-0719-2017
- Recalling firm
- Ivoclar Vivadent, Inc.
- Product
- Virtual XD Test Pack Heavy/Light Fast Set, 2 x 50 ml, REF #/Product Code 646469, Rx ONLY -- Product Usage: Dental impression material
- Status
- Terminated
- Initiated
- 2016-11-09
- Posted
- not on file
- Terminated
- 2018-06-18
- Reason
- The firm received complaints claiming the dental material failed to set up. As the dental material ages, the set time may increase.
- Root cause
- Under Investigation by firm
- Action
- Ivoclar Vivadent sent and URGENT - MEDICAL DEVICE RECALL Letters (dated 11/07/2016) and Recall Response Forms to customers via Certified Mail-Return Receipt Requested. The letter identified the affected product, problem and actions to be taken. Customers were advised to return all affected products in stock. For questions contact Ivoclar Vivadent Customer Service at 800-533-6825.
- Quantity
- US: 2090 units, Canada: 331 units, Australia: 465 units
- Distribution
- Worldwide Distribution - US Nationwide and the countries of Canada and Australia
- Lot, serial or model codes
- Lot No./Expiration Date: TL4095/Jan 15, 2017; TL4094/Jan 15, 2017
- 510(k) numbers
- ["K083739"]
- PMA numbers
- not on file
- Product code
- ELW
- Firm FEI
- 1316092
- Firm city
- Amherst
- Firm state
- NY
- Firm country
- not on file
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