Urgent Field Safety Notice For Orthodontic Metal Devices By American Orthodontics

Summary American Orthodontics has issued a Class I Field Safety Notice for orthodontic metal devices distributed in Germany and the EU. The notice indicates a safety concern with these devices, though specific details about the hazard are not provided in the available information. This classification affects orthodontic patients currently using or fitted with these products in the affected regions.

Recalling firm
American Orthodontics
Product
Orthodontic Metal Devices
Reason
Urgent Field Safety Notice for Orthodontic Metal Devices by American Orthodontics
Classification
Class I
Category
medical device recall
Country
Germany
Agency
BFARM
Recall date
2026-10-13
Status
Ongoing
Distribution
Germany / EU

Official recall notice from BFARM

Recall details on Nibble Recalls: https://trynibble.app/recalls/f8eb44f3-85db-4d22-928f-618181a80652