Virtual XD Refill Light Body Fast Set Wash Material, 2X50 ml, REF #/Product Code 646461, Rx ONLY -- product Usage: Dental impression material
This recall has been terminated (originally issued November 9, 2016).
- Company
- Ivoclar Vivadent, Inc.
- Recall Initiated
- November 9, 2016
- Terminated
- June 18, 2018
- Recall Number
- Z-0717-2017
- Quantity
- US: 4659 units, Canada: 729 units
- Firm Location
- Amherst, NY
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide Distribution - US Nationwide and the countries of Canada and Australia
Lot / Code Info
Lot No./Expiration Date: UL2395/June 28, 2018; UL2293/Dec 31, 2017; UL2222/Aug 28, 2017; UL2220/July 28, 2017; TL4121/ Mar 28, 2017
Root Cause
Under Investigation by firm
Action Taken
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.