Affinity™ Heavy Body RS 12pk 013912Recalls & reported problems
Clinician'S Choice Dental Products, Inc. · VPS Impression Material · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Mar 18, 2022Class IITerminated
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
Z-1100-2022 · Root cause: Process control · Recall details · FDA record ↗
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- EXAlence™ 137004Gc America Inc. · MATERIAL, IMPRESSION1 report
- Aquasil® Ultra+ Smart Wetting® Impression Material 678684Dentsply International Inc. · MATERIAL, IMPRESSION1 report
- Express™ 73123m Company · MATERIAL, IMPRESSION1 report
- hydrogum C302025Zhermack SPA · MATERIAL, IMPRESSION1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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