FLEXCERA SMILE -a Dental resins for the fabrication of artificial teeth
Reported: February 23, 2022 Initiated: January 6, 2022 #Z-0643-2022
Product Description
FLEXCERA SMILE -a Dental resins for the fabrication of artificial teeth
Reason for Recall
Manufactured in a non-FDA-registered manufacturing facility and product mislabeled as being of German origin
Details
- Recalling Firm
- Envisiontec US Llc
- Units Affected
- 795 units
- Distribution
- US Nationwide distribution.
- Location
- Dearborn, MI
Frequently Asked Questions
What product was recalled? ▼
FLEXCERA SMILE -a Dental resins for the fabrication of artificial teeth. Recalled by Envisiontec US Llc. Units affected: 795 units.
Why was this product recalled? ▼
Manufactured in a non-FDA-registered manufacturing facility and product mislabeled as being of German origin
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 23, 2022. Severity: Moderate. Recall number: Z-0643-2022.
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