Recall Z-1314-2014 ยท DYJ Retainer, Screw Expansion, Orthodontic
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.
| Date | Apr 1, 2014 (initiated Feb 24, 2014) |
| Status | Terminated |
| 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 iss |
| Quantity | 411 |
| Distribution | Worldwide Distribution: US (nationwide) and the country of : Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.