| TGA Action ID |
RC-2026-RN-00773-1 |
| Type of Product |
Biological |
| Product Name/Description |
Femoral Head (L) Non-irradiated, Non-processed
Allograft Number: 107425
Expiry Date: 01/08/2021 |
| ARTG Number |
231769 |
| Unique Device Identifier (UDI) |
Allograft number 107425 |
| Action Type |
Product Alert |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
A previous donor to the living donor femoral head program was diagnosed with metastatic lung cancer approximately 11 years following their femoral head donation. The femoral head was transplanted into a recipient patient on 3 March 2017.
There is a risk, albeit unlikely, that the recipient may have received compromised tissue.
Given the nature of the product, this action was undertaken prior to TGA notification (Immediate Market Action as defined within the PRAC). |
| Instructions for Customers/Users |
The TGA notes that at the time of retrieval for this particular donated bone, Queensland Tissue Bank requirements were met and that the relevant surgeon has been notified of this problem in writing.
This action has been closed out on 09/10/2026 |
| Action Commencement Date |
7/10/2026 |
| Responsible Entity |
|
| Contact Information |
(07) 3121 2626 - Metro South |