Product Safety Recalls

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Clinician’s Choice Dental Products Inc. Recall 90031

Description: 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

Clinician’s Choice Dental Products Inc. Recall 90031 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1100-2022
Event ID90031
Event DescriptionAffinity 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
Product TypeDevices
DistributionDistributed in SC.
Quantity46 units
Recall ReasonWrong compression material - Template Ultra Quick matrix Material was packaged instead of the Heavy Body viscosity as indicated on the outer packaging of the 12PK
Device Classification20220525
Device Code InfoLOT No.: 611612 (UDI): 07540172000178
Center Classification Date20220517
Recall Initiation Date20220318
Recalling FirmClinician's Choice Dental Products Inc.
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