Ivoclar Vivadent, Inc. Article No. NA6050411, Valiant PhD No. 1 Econo Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Article No. NA6050411, Valiant PhD No. 1 Econo
Brand
Ivoclar Vivadent, Inc.
Lot Codes / Batch Numbers
UDI-DI D707NA60504110, Lot Z066SD
Products Sold
UDI-DI D707NA60504110, Lot Z066SD
Ivoclar Vivadent, Inc. is recalling Article No. NA6050411, Valiant PhD No. 1 Econo due to Affected product may not perform as expected; the amalgam powder may not triturate correctly and the physical properties (i.e. strength, compression, . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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 information to them directly. Firm stated that product manufactured after December 6, 2023, were corrected for any irregularities. Customers with questions about risk minimizing safety measures may contact customercare.vigilance@ivoclar.com. For questions regarding replacement or credit note for products affected by this field safety notice, please contact customer service at Ivoclar Vivadent Inc at 1-800-533-6825.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026