FDA recall Z-2336-2021

Product

KeyPrint Soft- bottle, 32.5 oz (1kg). Resin for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints and repositioners. Model (Ref) #: 4220005

Reason for recall

Product label intended for the European community was distributed to the USA market via their US distribution organization

Distribution

US Nationwide distribution in the state of TX.

Key facts

Status

Ongoing

Initiation date

2021-06-25

Report date

2021-09-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Andover, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2336-2021