Ivoclar Vivadent, Inc. recalls Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501
- Recall date
- August 3, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0665-2018
- FDA classification
- Class III
- Brand / firm
- Ivoclar Vivadent, Inc.
- Sold / distributed
- US and Canada
Why it was recalled
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.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501
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