Z-1314-2014Class II

AOA Distalizer Lock Nut Screw, found in products listed as: Distal Jet, Spring Jet, Mesial Jet, and Uprighter...

Name: Z-1314-2014 AOA Distalizer Lock Nut Screw, found in products listed as: Distal Jet, Spring Jet, Mesial Jet, and Uprighter...
Creator: Allesee Orthodontic Appliances
Published: 2014-02-24
License: https://open.fda.gov/license/

Allesee Orthodontic Appliances, Inc. / initiated 2014-02-24 / Terminated / root cause: manufacturing process

FDA source

Allesee Orthodontic Appliances began a recall of AOA Distalizer Lock Nut Screw, found in products listed as: Distal Jet, Spring Jet, Mesial Jet, and Uprighter Jet. Removable functional orthodontic appliances... on 2014-02-24. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1314-2014
Classification: Class II
Status: Terminated
Initiated: 2014-02-24
Posted: 2014-04-01
Terminated: 2014-08-23
Recalling firm: Allesee Orthodontic Appliances, Inc.
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.
Product code: DYJ Retainer, Screw Expansion, Orthodontic
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: An advisory letter dated January 10, 2014 was sent to customers. The letter titled "ATTENTION: FIELD CORRECTIVE ACTION", informed customers the reason for recall, product description and devices affected dates of manufacturer, potential hazard, a photo comparison of a lock nut with screw collar and lock nut with no screw collar, instructions to the customers, and contact information. The letter was accompanied by an acknowledgement form titled "DISTALIZER JET LOCK NUT ACKNOWLEDGEMENT FORM". A follow up letter dated February 24, 2014 on March 7, 2014 to customers. This letter addresses the issue of the replacement screws as a follow up to the initial January 10, 2014 letter. The follow up letter, titled "ATTENTION: MEDICAL DEVICE RECALL" is dated Februray 24, 2014, refrences the January 10, 2014 letter that AOA sent, attaches the letter for reference, and informs customers that "AOA is now offering the option to obtain a Lock Nut with Screw Collar to replace within devices determined to be affected by this recall". The follow up letter informs customers of the reason for recall, the description and manufacturing dates of product affected, instructions to follow, and contact information. The customers were instructed to 1) continue to monitor the patient during the time of treatment; or 2) remove the device from the patient's mouth and return it to AOA for evaluation/replacement; or 3) request a replacement Lock Nut Screw with collar by contacting our Customer Support Department at 1-800-262-5221, and complete and return the attached acknowledgement form titled "DISTALIZER JET LOCK NUT RECALL ACKNOWLEDGEMENT FORM" via fax to 262-886-6879. If you have any questions, contact the Customer Support Department at 1-800-262-5221.
Quantity in commerce: 411
Distribution: Worldwide Distribution: US (nationwide) and the country of : Canada.
Product codes and lots: All Devices/Codes Manufactured from August 28, 2013 to November 6, 2013

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1314-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1314-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-09	2014-04-01

Product code DYJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)