Virtual XD Test Pack Heavy/Light Fast Set, 2 x 50 ml, REF #/Product Code 646469, Rx ONLY -- Product Usage: Dental impression material
FDA Recall Z-0719-2017 · Posted None
Recalling FirmIvoclar Vivadent, Inc.
Recall StatusTerminated
Product CodeELW
Date Initiated2016-11-09
Date Terminated2018-06-18
Product QuantityUS: 2090 units, Canada: 331 units, Australia: 465 units
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.
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.
Root Cause
Under Investigation by firm
Distribution Pattern
Worldwide Distribution - US Nationwide and the countries of Canada and Australia
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.