April 9, 2014Medical DevicesFDA
Allesee Orthodontic Appliances recalls AOA Distalizer Lock Nut Screw, found in products listed as: Distal Jet, Spring Jet, Mesial Jet, and Uprighter Jet. Remo
Hazard: 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.