| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00637-1 |
| Product Name/Description |
Logical Ceramic Liner
Serial Numbers: 111-22-1005 and 111-22-1007
Lot Numbers: 7010864573 and 7010862871 |
| Recall Action Level |
Sponsor |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
23/06/2014 |
| Responsible Entity |
|
| Reason/Issue |
The affected devices have been mislabeled. The contents of the packaging does not match the identification on the label.
This action was undertaken prior to notifying the TGA. |
| Recall Action |
Recall |
| Recall Action Instructions |
Surgical orthopaedics requested their customer to return the affected lots. This action was undertaken without consulting with theTGA. |
| Contact Information |
02 9428 5181 - Signature Orthopaedics |