Reported Apr 9, 2014 · Terminated
AOA Distalizer Lock Nut Screw, found in products listed as: Distal Jet, Spring Jet, Mesial Jet, and Uprighter Jet.…
Allesee Orthodontic Appliances
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Allesee Orthodontic Appliances · 13931 Spring St · Sturtevant, WI · 53177-1250
Is this the product you have?
- AOA Distalizer Lock Nut Screw
- found in products listed asDistal 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
- Lot codes and dates
- All Devices/Codes Manufactured from August 28, 2013 to November 6, 2013
- Amount recalled
- 411
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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