Recall Z-0053-2021
Ultradent Products, Inc. · initiated August 31, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
PermaFlo Flowable Composite REF-UP 948 Shade: A2 - Product Usage: is a light cured, radiopaque, methacrylate based, flowable composite. PermaFlo contains H1m average particle size with narrow upper limit particle distribution.
Codes / lots: Part Number - 948: PermaFlo A2 Refill Lot Number - BJR5W UPC Code - 8832505103918 UDI Code - 00883205103918
Reason for recall
Due to a potential manufacturing issue (cross contamination), composite is non-homogeneous.
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-0053-2021
- Initiated
- August 31, 2020
- Terminated
- October 18, 2021
- Product code
- EBF – Material, Tooth Shade, Resin
- Quantity
- 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.
- Recalling firm
- Ultradent Products, Inc., South Jordan, UT