Recall Z-1100-2022
Clinician's Choice Dental Products Inc. · initiated March 18, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: LOT No.: 611612 (UDI): 07540172000178
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
FDA-determined cause: Process control
Action taken
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
Details
- Recall number
- Z-1100-2022
- Initiated
- March 18, 2022
- Terminated
- March 19, 2024
- Product code
- ELW – Material, Impression
- Quantity
- 46 units
- Distribution
- Distributed in SC.
- Recalling firm
- Clinician's Choice Dental Products Inc., Brookfield, CT