PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: May 25, 2022 Initiated: March 18, 2022 #Z-1100-2022

Product 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

Reason for Recall

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

Details

Units Affected
46 units
Distribution
Distributed in SC.
Location
Brookfield, CT

Frequently Asked Questions

What product was recalled?
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. Recalled by Clinician's Choice Dental Products Inc.. Units affected: 46 units.
Why was this product recalled?
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
Which agency issued this recall?
This recall was issued by the FDA Devices on May 25, 2022. Severity: Moderate. Recall number: Z-1100-2022.