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U.S. Department of Health and Human Services

Class 2 Device Recall PermaFlo A2 Refill Flowable Composite

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  Class 2 Device Recall PermaFlo A2 Refill Flowable Composite see related information
Date Initiated by Firm August 31, 2020
Create Date October 02, 2020
Recall Status1 Terminated 3 on October 18, 2021
Recall Number Z-0053-2021
Recall Event ID 86432
510(K)Number K974413  
Product Classification Material, tooth shade, resin - Product Code EBF
Product PermaFlo Flowable Composite REF-UP 948 Shade: A2 - Product Usage: is a light cured, radiopaque, methacrylate based, flowable composite. PermaFlo contains H1¿m average particle size with narrow upper limit particle distribution.
Code Information Part Number - 948: PermaFlo A2 Refill Lot Number - BJR5W UPC Code - 8832505103918 UDI Code - 00883205103918
Recalling Firm/
Manufacturer		 Ultradent Products, Inc.
505 W 10200 S
South Jordan UT 84095-3800
For Additional Information Contact Shawn Quigley
801-553-4278
Manufacturer Reason
for Recall		 Due to a potential manufacturing issue (cross contamination), composite is non-homogeneous.
FDA Determined
Cause 2		 Under Investigation by firm
Action On August 31, 2020, the firm sent an URGENT FIRST NOTICE PRODUCT RECALL" notification to US customers via UPS (International customer via email on September 1, 2020) informing them of the potential product contamination that may affect the performance characteristics of the product to include, micro-hardness, bond strength, and wear and may pose an increased risk of restoration failure. Customers are instructed to discontinue use of the product immediately. Customers are also instructed to: -Complete the Return Response Form enclosed with this letter and Fax 801-553-4609 or email to shawn.quigley@ultradent.com. -Using the supplied shipping labels, return to Ultradent the completed form and all unused Product; and -Maintain a ledger of the patients treated with the Product, including the patients name and applicable treatment information. The Recalling Firm will send out replacement kits and issue an $100 credit to customer's accounts For questions regarding replacement product, contact Customer Service at 1-888-230-1420. For any questions regarding the recall, contact Customer Concerns at 801-553-4139.
Quantity in Commerce 412 syringes (206 kits)
Distribution Worldwide distribution - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, KS, IN, LA, MA, MD, ME, MI, MT, NC, NJ, NM, NY, NV, OH, OK, PA, SC, TN, TX, UT, VT, WA, and WI. The countries of Australia, Germany Japan and Mongolia.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = EBF and Original Applicant = ULTRADENT PRODUCTS, INC.
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