Brius Pontics (components in a set of custom metal orthodontic devices);BRIUS , RX Only, Non-Sterile, Custom Made Device
Summary
The FDA issued a Class II for Brius Pontics (components in a set of custom metal orthodontic devices);BRIUS , by Brius Technologies Inc.. Reason: Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being docu.
Details
Source
Device Recall
External ID
Z-0888-2022
Action Date
2022-04-13
Status
Terminated
Category
device
Product Description
Brius Pontics (components in a set of custom metal orthodontic devices);BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL
Lot/Code Info: 524947 .00BB (upper); 524925 .00BB (upper); 524503 .10Bn (upper); 523431 .20U; 524304 .10Bn (upper); 523595 .21bn (upper)
Quantity Affected: 6
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.
Distribution
US Nationwide: CA, DC, MA, NJ, NY, TX
Type: Voluntary: Firm initiated
Recall Initiated: 2022-02-07
Company
Carrollton, TX
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 149 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Brius Technologies Inc. has 4 FDA actions in our database, including 3 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Brius Technologies Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Brius Technologies Inc. have FDA actions?
Brius Technologies Inc. has 4 FDA actions in our database, including 3 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0888-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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