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 Zimmer Biomet Pty Ltd Zimmer Dermatome Blades [Product code: 00-8800-000-10; Multiple lot numbers] [HKMD No.: 150047].
According to the TGA, there have been 38 complaints received related to skin grafts being thin and non-uniform when using specific lots of the blades. The issue would be identified at the time of use and may result in the need for additional harvests to adequately cover the area.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-00804-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 14 Sep 2023