Z-0719-2017Class II

Virtual XD Test Pack Heavy/Light Fast Set, 2 x 50 ml, REF #/Product Code 646469, Rx ONLY --

Name: Z-0719-2017 Virtual XD Test Pack Heavy/Light Fast Set, 2 x 50 ml, REF #/Product Code 646469, Rx ONLY --
Creator: Ivoclar Vivadent, Inc.
Published: 2016-11-09
License: https://open.fda.gov/license/

Ivoclar Vivadent, Inc. / initiated 2016-11-09 / Terminated

FDA source

Ivoclar Vivadent, Inc. began a recall of Virtual XD Test Pack Heavy/Light Fast Set, 2 x 50 ml, REF #/Product Code 646469, Rx ONLY -- Product Usage: Dental impression material on 2016-11-09. FDA classified it as Class II and gives the reason as "The firm received complaints claiming the dental material failed to set up. As the dental material ages, the set time may increase". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0719-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-09
Posted: 2016-12-07
Terminated: 2018-06-18
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
Product code: ELW Material, Impression
Reason for recall: The firm received complaints claiming the dental material failed to set up. As the dental material ages, the set time may increase.
FDA 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 in commerce: US: 2090 units, Canada: 331 units, Australia: 465 units
Distribution: Worldwide Distribution - US Nationwide and the countries of Canada and Australia
Product codes and lots: Lot No./Expiration Date: TL4095/Jan 15, 2017; TL4094/Jan 15, 2017

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0719-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0717-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-14	2016-12-07
Z-0718-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-14	2016-12-07
Z-0719-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-14	2016-12-07

Product code ELW

K083739Class IIHydrorise and HydrosystemZhermack S.P.A. / cleared 2009-03-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)