Recall Z-1006-2024 ยท EJJ Alloy, Amalgam
Ivoclar Vivadent, Inc.
Article No. NA6050411, Valiant PhD No. 1 Econo
| Date | Feb 7, 2024 (initiated Dec 21, 2023) |
| Status | Open, Classified |
| Reason | Affected product may not perform as expected; the amalgam powder may not triturate correctly and the physical properties (i.e. strength, compression, working time, etc.) will be adversely affected. |
| Root cause | Employee error |
| Action | On December 19, 2023, the firm notified customers by phone. On December 21, 2023, the firm further notified affected customers via URGENT MEDICAL DEVICE RECALL letters through email. Customers were instructed to check their inventory for the affected lot and quarantine the product, and stop deliveries of the affected lot. Customers should respond to the letter and return all stock of affected product to the recalling firm. If product was further distributed, the customer should provide downstream customers' information to the recalling firm so that the firm may communicate recall informati |
| Quantity | 2 boxes (500 per box) |
| Distribution | US Nationwide distribution in the states IN and TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K820389 | A DENTAL AMALGAM ALLOY (UNNAMED Dentsply Intl., Mar 11, 1982 |