Medical device recalls

Ivoclar Vivadent, Inc. recalls Heliomolar Refill 20x0.25g 210/A3, Product code 541503AN, Catalog number 541503

Recall date
August 3, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0667-2018
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 210/A3, Product code 541503AN, Catalog number 541503

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