| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01366-1 |
| Product Name/Description |
Cheek Retractor, f/MatrixMANDIBLE U-shaped, flexible
Part Number: 397.232
Multiple lot numbers affected
ARTG Number: 153950 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
24/12/2014 |
| Responsible Entity |
|
| Reason/Issue |
The Cheek Retractor for MatrixMANDIBLE U-shaped may not function as intended due to the potential for corrosion and/or failure of the internal spring which has been manufactured from an incorrect material. As an internal part of the instrument, the spring is not in direct contact with the patient. However, in the event that the spring or a subcomponent of the spring was to fail and/or corrode, the possibility exists that the particles may transfer from the instrument to the patient, potentially leading to an adverse tissue reaction and/or infection. A surgical delay may also arise if the retractor does not work during a procedure and a replacement needs to be found.
To date, there have been no reports of adverse events related to this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are asked to inspect invetory and to follow the instructions provided for any affected units. To mitigate risk, should customers with affected instruments require the instrument for emergency cases, please perform a visual and functional inspection, as detailed in the cistomer letter, prior to, during and after use. Customers are asked to exercise caution regarding the risk of corrosion or spring breaking during the procedure. This action has been closed-out on 04/04/2017. |
| Contact Information |
1800 796 8437 - Synthes Australia Pty Ltd |