# FDA recall Z-0889-2022

> **Brius Technologies Inc.** · Class II · device recall initiated 2022-02-07.

## 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

- **Recall number:** Z-0889-2022
- **Recalling firm:** Brius Technologies Inc.
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-0889-2022. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-0889-2022. Source: US FDA. Licensed CC0.

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