| TGA Action ID |
RC-2025-RN-00506-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Apex Knee Modular Stem Cemented
Multiple part numbers, lot numbers and sizes |
| ARTG Number |
276775 |
| Action Type |
Recall / Product Alert |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
The Apex Knee Revision Stems are packed in a double sterile barrier system comprising of an inner and outer pouch made of nylon material.
Corin has identified batches of Apex Knee Revision Stems where the nylon material has exceeded its shelf life. Internal investigation has identified that the age of the nylon packaging material has caused a loss of integrity of some pouches. Investigations to date have not identified a double breach of pouch integrity.
There is a potential risk of the devices no longer being sterile. |
| Instructions for Customers/Users |
RECALL:
Customers are to:
- Quarantine affected stock on hand to prevent further use.
- Return affected stock to the address in the customer letter and replacement stock will be provided.
PRODUCT ALERT:
Customers are to be aware of the problem as outlined in the customer letter.
Corin Australia is advising that no extra patient follow up is required. Surgeons can continue their routine follow up.
This action has been finalised on 22/9/2025. |
| Action Commencement Date |
3/06/2025 |
| Responsible Entity |
|
| Contact Information |
02 9497 7400 - Corin Australia |