Recall Z-1314-2014— Allesee Orthodontic Appliances
Class II · Terminated
Class II FDA medical device recall by Allesee Orthodontic Appliances, initiated 2014-02-24, terminated 2014-08-23. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- Allesee Orthodontic Appliances
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-02-24
- Terminated
- 2014-08-23
- Firm location
- Sturtevant, WI, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.