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Ivoclar Vivadent, Inc. recalls Heliomolar Refill 20x0.25g 140/A2, Product code 541502AN, Catalog number 541502
Recalled February 28, 2018 · FDA recall Z-0666-2018 · Ivoclar Vivadent
Hazard
Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing and contouring. · FDA Class III
Units
3,255 units
Sold at
US and Canada
Description
Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing and contouring.
Product
Heliomolar Refill 20x0.25g 140/A2, Product code 541502AN, Catalog number 541502
Manufacturer(s)
Ivoclar Vivadent, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →