Clinician's Choice Dental Products Inc. 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Clinician's Choice Dental Products Inc.
Lot Codes / Batch Numbers
LOT No.: 611612 (UDI): 07540172000178
Products Sold
LOT No.: 611612 (UDI): 07540172000178
Clinician's Choice Dental Products Inc. is recalling Affinity Hydroactive Impression Material Heavy Body Regular Set 12PK- A vinyl poly siloxane material due to Wrong compression material - Template Ultra Quick matrix Material was packaged instead of the Heavy Body viscosity as indicated on the outer packaging. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
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 bwheal@clinicianschoice.com. Should you require any further information, please contact the undersigned at 1-800-265-3444 x 292
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN, SC
Page updated: Jan 10, 2026