Z-1314-2014 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 9, 2014
- Initiation Date
- February 24, 2014
- Termination Date
- August 23, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 411
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Worldwide Distribution: US (nationwide) and the country of : Canada.
Code Information
All Devices/Codes Manufactured from August 28, 2013 to November 6, 2013