Retiro De Equipo (Recall) de Device Recall Distalizer Lock Nut Screw

Recall

67647

Class 2

Z-1314-2014

2014-02-24

2014-04-01

Terminated

United States

2014-08-23

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125897

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.

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.