| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00080-1 |
| Product Name/Description |
RCI HA ACL Screw
Ligament anchor
Catalogue Number 35130415, 35130416
Batch Numbers: 750EE, 75188
Manufacture date: 31-07-2016
Expiry date: 31-07-2021
ARTG Number 193153
(Signature Orthopaedics Pty Ltd - Prosthesis, internal, ligament, anchor) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
25/01/2018 |
| Responsible Entity |
|
| Reason/Issue |
Signature Orthopaedics has been made aware of an incident where an RCI HA Screw (7x20mm) box was opened only to find a reverse threaded screw in the box. |
| 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 21/11/2018. |
| Contact Information |
02 9428 5181 - Signature Orthopaedics |