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
FDA Recall Z-1100-2022 · Posted None
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Recalling FirmClinician's Choice Dental Products Inc.
Recall StatusTerminated
Product CodeELW
Date Initiated2022-03-18
Date Terminated2024-03-19
Product Quantity46 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
Firm Action
Clinicians Choice Dental Products Inc issued Urgent Product Recall Letter on 3/22/22 to the US Distributor. Please contact all Customers who purchased the aforementioned LOT after November 12, 2021 and inform them IMMEDIATELY to stop using the product and return it to Henry Schein. Additionally, please examine your inventory to determine if you have any of the aforementioned product(s) in stock. Please discontinue sale IMMEDIATELY and return the entire stock of the denoted lot number to Clinician's Choice. Lastly, please complete the provided Form F-011A - Product Recall Record and return to [email protected]. Should you require any further information, please contact the undersigned at 1-800-265-3444 x 292
Root Cause
Process control
Distribution Pattern
Distributed in SC.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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