Recall Z-0890-2022 ยท DYJ Retainer, Screw Expansion, Orthodontic
Brius Technologies Inc.
Customized Brius Appliances (custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL
| Date | Feb 7, 2022 |
| Status | Terminated |
| Reason | Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, and released. |
| 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 |
| Quantity | 13 |
| Distribution | US Nationwide: CA, DC, MA, NJ, NY, TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.