| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00706-1 |
| Product Name/Description |
Score Extension Stem for Total Knee Prosthesis - Cemented
Multiple product codes affected
All lot numbers affected
ARTG number: 242001 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
10/06/2016 |
| Responsible Entity |
|
| Reason/Issue |
Amplitude has become aware through transport simulation tests that the packaging pouches of some devices could be damaged. The pouches function as the sterile barrier of the device packaging. There is a risk of infection if a patient is implanted with a non- sterile implant. The implantation of non-sterile device is unlikely. The routine tests conducted on devices did not show any case of non-sterility and no clinical incident was reported in relation with loss of sterility of the device. |
| Recall Action |
Recall |
| Recall Action Instructions |
Amplitude is advising users to inspect stock and quarantine any remaining units of the affected products for return. Patients with implanted devices should be followed up as per standard hospital procedures.
This action has been closed out on the 11/09/2018 |
| Contact Information |
08 8297 9901 - Amplitude |