Z-0890-2022Class II

Customized Brius Appliances (custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made...

Name: Z-0890-2022 Customized Brius Appliances (custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made...
Creator: Brius Technologies Inc.
Published: 2022-02-07
License: https://open.fda.gov/license/

BRIUS Technologies Inc. / initiated 2022-02-07 / Terminated / root cause: design

FDA source

Brius Technologies Inc. began a recall of Customized Brius Appliances (custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL on 2022-02-07. FDA classified it as Class II and gives the reason as "Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, and released". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0890-2022
Classification: Class II
Status: Terminated
Initiated: 2022-02-07
Posted: 2022-04-07
Terminated: 2024-10-18
Recalling firm: BRIUS Technologies Inc.
Product: Customized Brius Appliances (custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL
Product code: DYJ Retainer, Screw Expansion, Orthodontic
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.
Root cause tag: design
FDA root cause: Device Design
Action: On 2/28/22, the firm, Brius Technologies Inc., sent "URGENT: MEDICAL DEVICE RECALL" Letters (dated 2/21/2022) with an attached Acknowledgement and Receipt Response Form (Pontics, Patient Specific Brackets , and Customized Appliances), were sent to the respective Physicians via Fed-Ex first class trackable mail; a signed acknowledgement and receipt response was requested. Actions to be taken by the customer/user include the following: At this time, it is not recommended to remove the devices and interrupt the patient's treatment. However, physicians need to monitor their patients closely for adverse events. Additional Actions for Physicians and Patients with Pontics include in the letter: It is recommended that patients with Pontics be monitored for abnormal inflammation of tissues close to the location of the Pontics in the mouth. If the inflammation is thought to be an allergic response, it is recommended the removal of the device. Another cause of inflammation could be poor oral hygiene. In this case, it is not recommended to remove the Pontic. Additional Actions for Physicians and Patients with Patient Specific Brackets: All Brackets distributed prior to market release (7/22/21) have been removed from patients. No further actions are needed at this time. Additional Actions for Physicians and Patients with Customized Appliances: It is recommended that if the TAD (Temporary Anchorage Device) used with the customized device fails during treatment, the physician should remove the customized appliance and request a replacement appliance (that will not be customized to fit TADs). If customers have any questions they should contact: Elisabeth Miller [email protected],586-242-7718 Acknowledgment response forms should be completed and returned as follows: PLEASE EMAIL COMPLETED RESPONSE FORM TO: [email protected] OR MAIL TO: Attn: Michael Gregory 2611 Westgrove Dr. Ste109 Carrollton, TX 75006
Quantity in commerce: 13
Distribution: US Nationwide: CA, DC, MA, NJ, NY, TX
Product codes and lots: 523600 .40Bn Upper; 523738 .20BB Upper; 523927 .20Bn Upper; 524181 .01bl Lower; 524284 00U Upper; 524284 .01bn Upper; 524490 .02bn Upper; 524896 .00BB Upper; 525258 .00Bn Upper; 523431 .20U; 523431 .30U, 523431 .50U, 523431 .70U

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0890-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0888-2022	Class II	Terminated	Voluntary: Firm initiated	2022-04-13	2022-04-07
Z-0889-2022	Class II	Terminated	Voluntary: Firm initiated	2022-04-13	2022-04-07
Z-0890-2022	Class II	Terminated	Voluntary: Firm initiated	2022-04-13	2022-04-07

Product code DYJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)