Reported Feb 23, 2022 · Ongoing
FLEXCERA BASE -a Dental resins for the fabrication of artificial teeth
Envisiontec US LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Envisiontec US Llc · 15162 S Commerce Dr · Dearborn, MI · 48120-1237
Is this the product you have?
- FLEXCERA BASE -a Dental resins for the fabrication of artificial teeth
- Lot codes and dates
- Manufactured from April 1, 2021 to September 15,
228 of 228 codes
2021.120421-a7092130521180621d010421140621a060721a120421-b270521130521a090721a060421-a140621b060721b120421-c030621130521b090721b060421-b140621c060721c220421-a160721a130521c130721a060421-c150621a060721d220421-b160721b200521a130721b080421-a150621b070721a220421-c180721200521b130721c080421-b150621c070721b230621a280721200521c130721d080421-c210621a070721c230621b290721250521a300821a130421-a210621b070721d230621c100821250521b
- Manufactured from April 1, 2021 to September 15,
- Amount recalled
- 574 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Manufactured in a non-FDA-registered manufacturing facility and product mislabeled as being of German origin
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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