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Voco GmbH recalls Ionolux, Catalog (REF) Numbers: a) 2115, b)2117, c) 2118, d) 2119, e) 2120, f) 2122; dental cement
Recalled February 28, 2024 · FDA recall Z-1143-2024 · Voco
Hazard
Due to an error in the manufacturing process, it is possible that an incorrect plunger has been fitted to some capsules. This plunger does not contain the correct reactive component for Ionolux. When these capsules are activated, curing is significantly delayed and incomplete. Processing according to the instructions for use is not possible. · FDA Class II
Units
1021 units
Sold at
Worldwide distribution: US distribution to states of: IA, NY, PA, WA; and OUS (foreign) to countries of: Belgium, Bulgaria, Denmark, Germany, France, Greece, Great Britain, India, Italy, Canada, Quatar, Lithuania, Netherlands, Northern Ireland, Norway, Poland, Portugal, Romania, Sweden, Switzerland, Slovakia, Spain, Czech Republic, Australia, Saudi Arabia, & Ireland.
Description
Due to an error in the manufacturing process, it is possible that an incorrect plunger has been fitted to some capsules. This plunger does not contain the correct reactive component for Ionolux. When these capsules are activated, curing is significantly delayed and incomplete. Processing according to the instructions for use is not possible.
Product
Ionolux, Catalog (REF) Numbers: a) 2115, b)2117, c) 2118, d) 2119, e) 2120, f) 2122; dental cement
Manufacturer(s)
Voco GmbH
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →