Brookfield, CT, United States
Clinician's Choice Dental Products Inc. recalls
1 recall recorded since 2018, most recently on 18 March 2022. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 18 March 2022
- Terminated
- 19 March 2024
- 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
- Distribution
- Distributed in SC.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1100-2022
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.