FDA Medical Device Recalls (openFDA)
Allesee Orthodontic Appliances: 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.
- Recall number
- Z-1314-2014
- Recalling firm
- Allesee Orthodontic Appliances
- 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.
- Status
- Terminated
- Initiated
- 2014-02-24
- Posted
- 2014-04-01
- Terminated
- 2014-08-23
- 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.
- 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
- 411
- Distribution
- Worldwide Distribution: US (nationwide) and the country of : Canada.
- Lot, serial or model codes
- All Devices/Codes Manufactured from August 28, 2013 to November 6, 2013
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DYJ
- Firm FEI
- 1000128562
- Firm city
- Sturtevant
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28