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Ivoclar Vivadent, Inc. recalls Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501
Recalled February 28, 2018 · FDA recall Z-0665-2018 · 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
2,153 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 110/A1, Product code 541501AN, Catalog number 541501
Manufacturer(s)
Ivoclar Vivadent, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →