Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
The Australian Therapeutic Goods Administration (TGA) has posted a medical device safety alert concerning Depuy (Ireland) Attune Cementless CR Femur [Product code: 150401204; Lot number: 3883327] [HKMD No.: 200111].
According to the TGA, the product was packaged and labelled as a size 4, but the implant had the dimensions of a size 5. It was confirmed that this issue is limited to a single affected lot of 12 implants globally of which 3 units were received and distributed in Australia.
For further information, please visit https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2023-RN-00769-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 28 Aug 2023