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Allesee Orthodontic Appliances recalls AOA Distalizer Lock Nut Screw, found in products listed as: Distal Jet, Spring Jet, Mesial Jet, and Uprighter Jet. Remo
Recalled April 9, 2014 · FDA recall Z-1314-2014 · Allesee Orthodontic Appliances
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. · FDA Class II
Units
411
Sold at
Worldwide Distribution: US (nationwide) and the country of : Canada.
Description
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.
Product
AOA Distalizer Lock Nut Screw, found in products listed as: Distal Jet, Spring Jet, Mesial Jet, and Uprighter Jet. Removable functional orthodontic appliances that are to modify the growth of the jaws in a prescribed growth pattern.
Manufacturer(s)
Allesee Orthodontic Appliances
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →