Recall Z-0053-2021 ยท EBF Material, Tooth Shade, Resin
Ultradent Products, Inc.
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.
| Date | Aug 31, 2020 |
| Status | Terminated |
| Reason | Due to a potential manufacturing issue (cross contamination), composite is non-homogeneous. |
| Root cause | 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.qu |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K974413 | PERMAFLO Ultradent Products, Inc., Feb 2, 1998 |