Affinity Hydroactive Impression Material Heavy Body Regular… recallZ-1100-2022 · Clinician's Choice Dental Products Inc. · initiated Mar 18, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Clinician's Choice Dental Products Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Process control
What the company is doing
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
Recall details
- Recall number
- Z-1100-2022
- Status
- Terminated
- Initiated by the company
- Mar 18, 2022
- Recalling firm
- Clinician's Choice Dental Products Inc.
- Quantity
- 46 units
- Product code
- ELW
- FDA submissions
- K053014
- Distribution
- Distributed in SC.
Product description
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
Code information (models, lots, serial numbers)
LOT No.: 611612 (UDI): 07540172000178
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Affinity™ Heavy Body RS 12pk 013912Clinician'S Choice Dental Products, Inc. · MATERIAL, IMPRESSION1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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