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Brius Technologies Inc. Recall 89569

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

Brius Technologies Inc. Recall 89569 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0889-2022
Event ID89569
Event DescriptionBrius Patient Specific Brackets (components in a set of custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL
Product TypeDevices
DistributionUS Nationwide: CA, DC, MA, NJ, NY, TX
Quantity4
Recall ReasonPontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, and released.
Device Classification20220413
Device Code Info523758 .00nB, 523798 .00BB; 523918 .00BB; 523570 .00BB
Center Classification Date20220407
Recall Initiation Date20220207
Recalling FirmBrius Technologies Inc.
Initial Notification Letter
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