FDA (Devices) recall action 89569
The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, and released.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Brius Technologies is recalling Brius Patient Specific Brackets that were sold before the company completed the required design control process and regulatory documentation.
Brius Technologies is recalling 13 customized metal orthodontic appliances that were sold and distributed prior to completing the required design control process and documentation.
Brius Technologies recalls Brius Pontics custom orthodontic devices that were sold before completing required design control procedures and documentation.