FDAFDA · Food and drugs·Recall number Z-1314-2014
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.
Published April 9, 2014 · Recall initiated: February 24, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Allesee Orthodontic Appliances
- Distributor
- Worldwide Distribution: US (nationwide) and the country of : Canada.
- Lot
- All Devices/Codes Manufactured from August 28, 2013 to November 6, 2013
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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