FDA recall Z-0643-2022

Product

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

Distribution

US Nationwide distribution.

Key facts

Status

Ongoing

Initiation date

2022-01-06

Report date

2022-02-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Dearborn, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0643-2022