Recall Z-0719-2017
Ivoclar Vivadent, Inc. · initiated November 9, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Virtual XD Test Pack Heavy/Light Fast Set, 2 x 50 ml, REF #/Product Code 646469, Rx ONLY -- Product Usage: Dental impression material
Codes / lots: Lot No./Expiration Date: TL4095/Jan 15, 2017; TL4094/Jan 15, 2017
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-determined 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.
Details
- Recall number
- Z-0719-2017
- Initiated
- November 9, 2016
- Terminated
- June 18, 2018
- Product code
- ELW – Material, Impression
- Quantity
- US: 2090 units, Canada: 331 units, Australia: 465 units
- Distribution
- Worldwide Distribution - US Nationwide and the countries of Canada and Australia
- Recalling firm
- Ivoclar Vivadent, Inc., Amherst, NY
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0717-2017 Class II | Virtual XD Refill Light Body Fast Set Wash Material, 2X50 ml, REF #/Product Code 646461…The firm received complaints claiming the dental material failed to set up. As the dental material ages, the… | 11/09/2016Terminated |
| Z-0718-2017 Class II | Virtual XD Refill Light Body Regular Set Wash Material, 2X50 ml, REF #/Product Code…The firm received complaints claiming the dental material failed to set up. As the dental material ages, the… | 11/09/2016Terminated |