| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01490-1 |
| Product Name/Description |
Apex Knee System
Model Number: KC-2206L
Lot Number: 26519
Expiry Date: 31/03/2022
ARTG Number: 278528 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
5/12/2017 |
| Responsible Entity |
|
| Reason/Issue |
The Apex Knee System Tibial Baseplate identified has an improper expiration date marked on the external packaging. The improper expiration date (2202-03) is marked on the external packaging only. The correct lot number (2022-03) is present in the internal packaging and sterile batch documentation.
This action has been undertaken prior to consultation with the Therapeutic Goods Administration (TGA). |
| Recall Action |
Recall |
| Recall Action Instructions |
Global Orthopaedic has advised users to quarantine and return all unused devices.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
02 8887 0100 - Customer Service |