Data Foundry

Medical device recalls 2014

AOA Distalizer Lock Nut Screw — Class II medical device recall Z-1314-2014

Terminated recall by Allesee Orthodontic Appliances, reported 2014-04-09, distributed nationwide. The Lock Nut component of the Jet appliances may be missing the screw collar, which serves as a mechanical sto

Recall numberZ-1314-2014
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmAllesee Orthodontic Appliances, Sturtevant, WI, United States
Recall initiated2014-02-24
Classified2014-04-01
Reported by FDA2014-04-09
Terminated2014-08-23
DistributedNationwide (US)
Countries outside the USCA
Quantity411

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 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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1314-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.