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 Smith & Nephew, Inc. OXINIUM FEMORAL HEAD 12/14 32MM +4 [Product Number: 71343204; Batch Number: 23FM03219; UDI: 03596010474223] [HKMD No.: 220228].
According to the TGA, a complaint was received indicating that a package contained an OXINIUM FEM HD 12/14 36 MM M/+4 implant instead of an OXINIUM FEM HD 12/14 32MM +4 as described on the product label.
For further information, please visit https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2024-RN-00353-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 09 May 2024