| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00484-1 |
| Product Name/Description |
RCI HA ACL Screw
Catalogue Number: 35130416
Batch Numbers: 750ED, 7515D
Manufacturing Date: 31-7-16
Expiry Date: 31-7-21
ARTG Number: 193153
(Signature Orthopaedics - Prosthesis, internal, ligament, anchor) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
14/05/2018 |
| Responsible Entity |
|
| Reason/Issue |
Signature Orthopaedics has identified that certain batches may be mislabelled, with the packaged component's size not corresponding to the label. Therefore, the product intended to be used for the procedure may not be included in the packaging. |
| Recall Action |
Recall |
| Recall Action Instructions |
Signature Orthopaedics is advising users to quarantine affected stock for return. Replacement stock or a credit note will be issued.
This action has been closed out on the 22/11/2018. |
| Contact Information |
02 9428 5181 - Signature Orthopaedics |