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 International Limited T/A DePuy CMW BIOSTOP G Bioresorbable Cement Restrictor [Models numbers: 546308000, 546310000, 546312000, 546314000, 546316000, 546318000 & 546320000] [HKMD No.: 090150].
According to the TGA, the manufacturer is recalling all lots of BIOSTOP G Bioresorbable Cement Restrictor as a precautionary measure because recent in vitro testing of endotoxin levels from a sample restrictor fully dissolved in solution were calculated at >20,000 endotoxin units (EU)/device over 24 hours, based on restrictor size.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-01549-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 19 Dec 2022