FDA Medical Device Recalls (openFDA)
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 number
- Z-1100-2022
- Recalling firm
- Clinician's Choice Dental Products Inc.
- 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
- Status
- Terminated
- Initiated
- 2022-03-18
- Posted
- not on file
- Terminated
- 2024-03-19
- 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 bwheal@clinicianschoice.com. Should you require any further information, please contact the undersigned at 1-800-265-3444 x 292
- Quantity
- 46 units
- Distribution
- Distributed in SC.
- Lot, serial or model codes
- LOT No.: 611612 (UDI): 07540172000178
- 510(k) numbers
- K053014
- PMA numbers
- not on file
- Product code
- ELW
- Firm FEI
- 2018957
- Firm city
- Brookfield
- Firm state
- CT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28