Z-1006-2024Class II

Article No. NA6050411, Valiant PhD No. 1 Econo

Name: Z-1006-2024 Article No. NA6050411, Valiant PhD No. 1 Econo
Creator: Ivoclar Vivadent, Inc.
Published: 2023-12-21
License: https://open.fda.gov/license/

Ivoclar Vivadent, Inc. / initiated 2023-12-21 / Open, Classified / root cause: manufacturing process

FDA source

Ivoclar Vivadent, Inc. began a recall of Article No. NA6050411, Valiant PhD No. 1 Econo on 2023-12-21. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1006-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-12-21
Posted: 2024-02-07
Recalling firm: Ivoclar Vivadent, Inc.
Product: Article No. NA6050411, Valiant PhD No. 1 Econo
Product code: EJJ Alloy, Amalgam
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.
Root cause tag: manufacturing process
FDA 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 [email protected]. 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 in commerce: 2 boxes (500 per box)
Distribution: US Nationwide distribution in the states IN and TN.
Product codes and lots: UDI-DI D707NA60504110, Lot Z066SD

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1006-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1006-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-14	2024-02-07

Product code EJJ

K820389Class IIA Dental Amalgam Alloy (UnnamedDentsply Intl. / cleared 1982-03-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)