FDAMarch 18, 2022device

Affinity Hydroactive Impression Material Heavy Body Regular Set 12PK- A vinyl poly siloxane material used to create, via impression, a reproduction of tooth and gum structure. Product ID: 013912

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Wrong compression material - Template Ultra Quick matrix Material was packaged instead of the Heavy Body viscosity as indicated on the outer packaging of the 12PK

What to do

FDA enforcement status: Terminated

Brands named

clinician s choice dental productsclinician

UPCs

07540172000178

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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