Class 2 Device Recall Distalizer Lock Nut Screw

• Date Initiated by Firm: February 24, 2014
• Date Posted: April 01, 2014
• Recall Status: Terminated on August 23, 2014
• Recall Number: Z-1314-2014
• Recall Event ID: 67647
• Product Classification: Retainer, screw expansion, orthodontic - Product Code DYJ
• 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.
• Code Information: All Devices/Codes Manufactured from August 28, 2013 to November 6, 2013
• Recalling Firm/ Manufacturer: Allesee Orthodontic Appliances; 13931 Spring St; Po Box 725; Sturtevant WI 53177-1250
• For Additional Information Contact: 414-886-1050
• Manufacturer 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.
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.