| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00083-1 |
| Product Name/Description |
Custom Made Implant Systems with Minimally Invasive Grower (MIG) component
Components implanted prior to October 2014
Item Numbers: 13271, 14092, 14205, 15757, 16782, 17944
These items are custom made to the patients ID and exempt from ARTG Numbers |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
30/01/2018 |
| Responsible Entity |
|
| Reason/Issue |
In March 2007 the Minimum Invasive Grower (MIG) component with locking mechanism was utilised with custom made long bone replacement implants for limb salvage procedures of skeletally immature or juvenile patients, to prevent unintended changes in the length of the device. The Instructions for Use (IFU) for these types of devices did not clarify the function of the locking mechanism and the warnings related to the locking screw until October 2014, resulting in potential lack of awareness of the locking mechanism and its function during that time.
The omission of this information in the IFU has been identified as a potential risk in risk management files for custom made devices, with the potential effects including; prolonged surgery, instability, pain, impaired function (gait) and early revision. Limb length discrepancy was also identified as a potential effect based on complaints data review. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
Patients implanted with an affected lot number of the Custom Implants with MIG component should continue to be followed per the normal protocol established by his/her surgeon.
This action has been closed out on 13/11/2018 |
| Contact Information |
02 9467 1175 - Customer Service Centre |