Affinity Hydroactive Impression Material Heavy Body Regular Set 12PK- A vinyl poly siloxane material used to create, via
Summary
The FDA issued a Class II for Affinity Hydroactive Impression Material Heavy Body Regular Set 12PK- A vinyl po by Clinician's Choice Dental Products Inc.. Reason: Wrong compression material - Template Ultra Quick matrix Material was packaged instead of the Heavy Body viscosity as indicated on the outer packaging.
Details
Source
Device Recall
External ID
Z-1100-2022
Action Date
2022-05-25
Status
Terminated
Category
device
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
Lot/Code Info: LOT No.: 611612 (UDI): 07540172000178
Quantity Affected: 46 units
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
Distribution
Distributed in SC.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-03-18
Company
Brookfield, CT
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 164 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Clinician's Choice Dental Products Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Clinician's Choice Dental Products Inc. have FDA actions?
This is the only FDA action we have on record for Clinician's Choice Dental Products Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1100-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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