FDA recall Z-0889-2022

Product

Brius Patient Specific Brackets (components in a set of custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL

Reason for recall

Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, and released.

Distribution

US Nationwide: CA, DC, MA, NJ, NY, TX

Key facts

Status

Terminated

Initiation date

2022-02-07

Report date

2022-04-13

Termination date

2024-10-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Carrollton, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0889-2022