Allesee Orthodontic Jet Appliances Recalled Due to Missing Screw Collar
Allesee Orthodontic Appliances is recalling 411 Jet appliances because a missing screw collar may prevent intended tooth movement.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a mechanical defect that prevents the intended therapeutic function of the device without reported injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Allesee Orthodontic Appliances is recalling 411 units of AOA Distalizer Lock Nut Screws found in Distal Jet, Spring Jet, Mesial Jet, and Uprighter Jet appliances. These are removable functional orthodontic appliances designed to modify jaw growth. The recall covers devices manufactured between August 28, 2013, and November 6, 2013, which were distributed nationwide in the United States and in Canada.
The recall is issued because the Lock Nut component may be missing a screw collar. This collar serves as a mechanical stop to prevent over-tightening during assembly. If the collar is missing, an over-tightened lock nut may stop the piston assembly from moving freely, which prevents the intended movement of the teeth.
Patients using these appliances should contact their orthodontist or the recalling firm for instructions on how to proceed. The source text does not report any injuries or illnesses associated with this defect.
The recalled product
- 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.
- Manufacturer
- Allesee Orthodontic Appliances
- Affected units
- 411
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- All Devices/Codes Manufactured from August 28
- 2013 to November 6
- 2013
Distribution
Distributed nationwide across the United States.
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