Class 2 Device Recall Brius Patient Specific Brackets

• Date Initiated by Firm: February 07, 2022
• Create Date: April 07, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0889-2022
• Recall Event ID: 89569
• Product Classification: Retainer, screw expansion, orthodontic - Product Code DYJ
• Product: Brius Patient Specific Brackets (components in a set of custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL
• Code Information: 523758 .00nB, 523798 .00BB; 523918 .00BB; 523570 .00BB
• Recalling Firm/ Manufacturer: Brius Technologies Inc.; 2611 Westgrove Dr; Carrollton TX 75006-2349
• For Additional Information Contact: Mehdi Roein Peikar; 234-564-3134
• Manufacturer 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.
• FDA Determined 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 emiller@primepathmedtech.com,586-242-7718 Acknowledgment response forms should be completed and returned as follows: PLEASE EMAIL COMPLETED RESPONSE FORM TO: Michael.Gregory@brius.com OR MAIL TO: Attn: Michael Gregory 2611 Westgrove Dr. Ste109 Carrollton, TX 75006
• Quantity in Commerce: 4
• Distribution: US Nationwide: CA, DC, MA, NJ, NY, TX
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.