Recall Z-1100-2022 ยท ELW Material, Impression
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
| Date | Mar 18, 2022 |
| Status | Terminated |
| Reason | 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 |
| Root cause | Process control |
| 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 |
| Quantity | 46 units |
| Distribution | Distributed in SC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053014 | POLY SILOXANE IMPRESSION MATERIAL Clinician'S Choice Dental Products, Inc., Nov 15, 2005 |