FDA Medical Device Recalls (openFDA)
Ivoclar Vivadent, Inc.: Article No. NA6050411, Valiant PhD No. 1 Econo
- Recall number
- Z-1006-2024
- Recalling firm
- Ivoclar Vivadent, Inc.
- Product
- Article No. NA6050411, Valiant PhD No. 1 Econo
- Status
- Open, Classified
- Initiated
- 2023-12-21
- Posted
- 2024-02-07
- Terminated
- not on file
- 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 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.
- Quantity
- 2 boxes (500 per box)
- Distribution
- US Nationwide distribution in the states IN and TN.
- Lot, serial or model codes
- UDI-DI D707NA60504110, Lot Z066SD
- 510(k) numbers
- ["K820389"]
- PMA numbers
- not on file
- Product code
- EJJ
- Firm FEI
- 1316092
- Firm city
- Amherst
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28