| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00091-1 |
| Product Name/Description |
Signature Ceramic Femoral Head
Catalogue Number: 111-152-621
Batch Numbers: 78560, 78528
Manufacture Date: 31/10/2017
Expiry Date: 31/10/2022
ARTG Number: 272595 |
| Recall Action Level |
Wholesale |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
5/02/2018 |
| Responsible Entity |
|
| Reason/Issue |
Signature Orthopaedics has been made aware that a 28 (S) Femoral Head was found labelled as a 32 (S) Ceramic Femoral Head. Investigation of production records confirmed that these batches may be mislabelled, with the packaged component's size not corresponding to the label. |
| Recall Action |
Recall |
| Recall Action Instructions |
Signature Orthopaedics is advising users to quarantine all stock of the affected lot numbers and return to the sponsor.
This action has been closed out on 7/09/2018. |
| Contact Information |
02 9428 5181 -Customer Service Support |