CLASS II Device recall · Reported 25 May 2022 · FDA Enforcement Report
Affinity Hydroactive Impression Material Heavy Body Regular recalled
Clinician's Choice Dental Products is recalling Affinity Hydroactive Impression Material Heavy Body Regular Set- A vinyl poly siloxane, distributed in South Carolina. The recall was initiated on 18 Mar 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1100-2022
- FDA event ID
- 90031
- Recalling firm
- Clinician's Choice Dental Products, Brookfield, CT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Mar 2022
- FDA classified
- 17 May 2022
- Reported
- 25 May 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 18 Mar 2022 | Recall initiated by company | |
| 17 May 2022 | Classified by FDA | +60 days |
| 25 May 2022 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
Distributed in SC.
Questions about this recall
Is Affinity Hydroactive Impression Material Heavy Body Regular Set- A vinyl poly siloxane recalled?
Yes. Clinician's Choice Dental Products recalled Affinity Hydroactive Impression Material Heavy Body Regular Set- A vinyl poly siloxane on 18 Mar 2022. The recall is Class II and its status is Terminated. Recall number Z-1100-2022.
Why was it 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
Which lots are affected?
LOT No.: 611612 (UDI): 07540172000178
Where was it sold?
Distributed in SC.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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