FDAClass IIMay 25, 2022

Affinity Hydroactive Impression Material Heavy Body recall

Affinity Hydroactive Impression Material Heavy Body Regular Set 12PK- A vinyl poly siloxane material used to create, via impression, a reproduction of…

Why was Affinity Hydroactive Impression Material Heavy Body 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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

LOT No.: 611612 (UDI): 07540172000178

Product
Affinity Hydroactive Impression Material Heavy Body Regular Set 12PK- A vinyl poly siloxane material used to create, via impression, a reproduction of…
Recalling firm
Clinician's Choice Dental Products Inc.
Quantity
46 units
Distribution
Distributed in SC.
Recall date
May 25, 2022
Classification
Class II
Status
Terminated
Agency
FDA (device)
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