Class 2 Device Recall DENTEMP ONE STEP

• Date Initiated by Firm: June 23, 2022
• Date Posted: August 17, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1529-2022
• Recall Event ID: 90650
• 510(K)Number: K964773
• Product Classification: Cement, dental - Product Code EMA
• Product: DENTEMP ONE STEP .077OZ, SKU 902139
• Code Information: All product sold between May 1, 2022 - June 10, 2022.
• Recalling Firm/ Manufacturer: Family Dollar Stores, Llc.; 500 Volvo Pkwy; Chesapeake VA 23320-1604
• Manufacturer Reason for Recall: Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
• FDA Determined Cause: Storage
• Action: On June 23, 2022, the firm notified affected Family Dollar retail stores via an urgent Pull and Hold notice, effective June 24, 2022. Retail stores were informed that due to a shipping issue, the affected products could not be sold. Stores were instructed to remove affected products from the sales floor and quarantine them. https://www.familydollar.com/file/general/Voluntary_Recall_of_Certain_Over_the_Counter_Products_080522.pdf
• Quantity in Commerce: 3122
• Distribution: Product distributed to Family Dollar retail stores in US nationwide.
• 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 = EMA and Original Applicant = MAJESTIC DRUG CO., INC.