Article No. NA6050411, Valiant PhD No. 1 Econo
FDA device recall Z-1006-2024 · posted 2024-02-07 · Open, Classified
Recall details
- Recalling firm
- Ivoclar Vivadent, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Employee error
- Status
- Open, Classified
- Product code
- EJJ
- Quantity affected
- 2 boxes (500 per box)
- Distribution
- US Nationwide distribution in the states IN and TN.
- Date initiated
- 2023-12-21
- Date posted
- 2024-02-07
- Location
- Amherst, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| A DENTAL AMALGAM ALLOY (UNNAMED (K820389) | Dentsply Intl. | 1982-03-11 |