Retainer, Screw Expansion, Orthodontic

AOA Distalizer Lock Nut Screw, found in products listed as: Distal Jet, Spring Jet, Mesial Jet, and Uprighter Jet. Removable functional orthodontic appliances

The Lock Nut component of the Jet appliances may be missing the screw collar, which serves as a mechanical stop to prevent over-tightening in appliance assemby. Without this collar, an over-tightened lock nut may stop the piston assembly from moving freely, subsequently preventing intended movement of the teeth.

AOA Mini RPE Screw Assembly , a component of

The firm initiated the recall of AOA Mini RPE Screw Assembly, because it may be missing a complete weld joining one side of the arm with the screw body. Herbst, MARA and Fixed Metal devices may be affected, because they contain an AOA Mini RPE Screw Assembly.

AdvanSync is an orthodontic device intended for the orthodontic treatment of Class II malocclusions. The AdvanSync part numbers and lot numbers affected by thi

Manufacturing Error: There is a potential for a braze joint failure in the upper telescopic rod assembly. Although an incident could occur in which the eyelet loses connection from the rod, there is no risk of swallowing or aspirating the appliance because it will still be attached to the patient's crown.

Brius Pontics (components in a set of custom metal orthodontic devices);BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL

Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, and released.

Brius Patient Specific Brackets (components in a set of custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL

Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, and released.

Customized Brius Appliances (custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL

Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, and released.