Home / Recalls / Medical Devices
Ultradent Products, Inc. recalls PermaFlo Flowable Composite REF-UP 948 Shade: A2 - Product Usage: is a light cured, radiopaque, methacrylate based, flow
Recalled October 14, 2020 · FDA recall Z-0053-2021 · Ultradent Products
Hazard
Due to a potential manufacturing issue (cross contamination), composite is non-homogeneous. · FDA Class II
Units
412 syringes (206 kits)
Sold at
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.
Description
Due to a potential manufacturing issue (cross contamination), composite is non-homogeneous.
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.
Manufacturer(s)
Ultradent Products, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →