FDAFDA · Food and drugs·Recall number Z-0889-2022
Brius Patient Specific Brackets (components in a set of custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL
Published April 13, 2022 · Recall initiated: February 7, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, and released.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Brius Technologies Inc.
- Distributor
- US Nationwide: CA, DC, MA, NJ, NY, TX
- Lot
- 523758 .00nB, 523798 .00BB; 523918 .00BB; 523570 .00BB
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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