Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall 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

U.S. FDA — Device Enforcement · United States · 2022-02-07 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0889-2022
Date of alert
2022-02-07
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Brius Technologies Inc.
Product category
device
Product type
Devices
Reported risk: Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, and released.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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