| TGA Action ID |
RC-2026-RN-00677-1 |
| Type of Product |
Biological |
| Product Name/Description |
Femoral Head (R) Allograft
Non-irradiated, non-processed
Allograft Reference Number: 114952 |
| ARTG Number |
231769 |
| Action Type |
Product Alert |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
A previous donor to the living donor program was referred to Queensland Tissue Bank as a deceased donor. Initial screening revealed that the donor was diagnosed with a melanoma in-situ (lentigo maligna) in November 2025, approximately nine (9) years after the donation of their right femoral head in 2016. The femoral head was implanted into the recipient on 25 September 2018. Allograft 114952 was not processed and not irradiated.
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 |
Customer letter to be sent to recipient's transplanting surgeon.
Implanting surgeons should note that, while the risk is unlikely, there remains a theoretical possibility that compromised tissue may have been received.
This action has been closed out on 09/09/2026 |
| Action Commencement Date |
4/09/2026 |
| Responsible Entity |
|
| Contact Information |
(07) 3121 2626 - Queensland Tissue Bank |