| 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 |
|
| 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 |