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U.S. Department of Health and Human Services

Class 2 Device Recall Valiant PhD No. 1 Econo

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  Class 2 Device Recall Valiant PhD No. 1 Econo see related information
Date Initiated by Firm December 21, 2023
Date Posted February 07, 2024
Recall Status1 Open3, Classified
Recall Number Z-1006-2024
Recall Event ID 93796
510(K)Number K820389  
Product Classification Alloy, amalgam - Product Code EJJ
Product Article No. NA6050411, Valiant PhD No. 1 Econo
Code Information UDI-DI D707NA60504110, Lot Z066SD
Recalling Firm/
Manufacturer		 Ivoclar Vivadent, Inc.
175 Pineview Dr
Amherst NY 14228-2231
For Additional Information Contact Mr. Chester Spivey
716-691-0010
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 2 boxes (500 per box)
Distribution US Nationwide distribution in the states IN and TN.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = EJJ and Original Applicant = DENTSPLY INTL.
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