Device 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.
Z-1314-2014
Product summary
- Event
- Event 67647
- Status
- Terminated
- Classification
- Class II
- Quantity
- 411
- Official record key
device-enforcement:Z-1314-2014
Official wording
Reason: 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.
Code information: All Devices/Codes Manufactured from August 28, 2013 to November 6, 2013
Distribution pattern: Worldwide Distribution: US (nationwide) and the country of : Canada.
Derived failure modes
-
Unknown
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.