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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00614-1
Product Name/Description Mini RPE Screw Assembly (Orthodontic Appliance System)

Mandibular Anterior Repositioning Appliance (M.A.R.A.)

Part number: 3000-0012

All Devices manufactured from 3 April 2013 to 21 May 2013.

ARTG Number: 110055
Recall Action Level Retail
Recall Action Classification Class II
Recall Action Commencement Date 25/06/2013
Responsible Entity Ormco Pty Ltd
Reason/Issue Ormco has become aware that the RPE Screw Assembly in Palate Expander devices is missing a complete weld joining one side of the arm with the screw body. Only a single device potentially affected by this issue is in use.
Recall Action Recall
Recall Action Instructions Ormco are asking their customer to inspect the patient's device at their next appointment. If an incomplete weld is identified, the orthodontist is required to either continue to monitor the patient during the time the palate expander treatment or remove the device and return to Ormco for replacement,
Contact Information 1800 643 603 - Ormco Customer Care