| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01236-1 |
| Product Name/Description |
A-642100 fixed offset adaptor (used in external prosthesis)
All units sold since 1 January 2008 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
21/11/2013 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer has received reports of the affected devices developing fatigue cracks in normal use over an extended period of time and may ultimately separate. Since there is hardly any visible or audible sign indicating potential breakage, Ossur strongly recommends the retrieval of all components in the field. No injuries resulting from such a failure have been reported and this is a precautionary step.
This recall action was carried out prior to the approval of the recall strategy by the TGA. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Ossur is recommending patients have the affected component replaced with a different component, and return any remaining inventory to Ossur. |
| Contact Information |
02 8838 2800 - Ossur Asia-Pacific |