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 Synthes GmbH VA-LCP Clavicle Plate 2.7, shaft, CS1, right [Product code: 02.112.621S; Lot number: 1201P12] [HKMD numbers: 190225].
According to TGA, the affected VA-LCP Clavicle Plate Shaft is being recalled as sterility cannot be confirmed for lot 1201P12. While manufacturing conditions of the subject devices are maintained to reduce contamination, their use may result in infection.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2024-RN-00093-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 15 Feb 2024