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.
Medical device manufacturer, Ethicon, has issued a medical device safety alert concerning PDS II (polydioxanone) Suture [Product Codes: PDP9615H, PDP9865H] and PDS Plus Antibacterial (polydioxanone) Suture [Product Code: W9861T] [HKMD No.: 110164].
According to the manufacturer, the manufacturer received seven complaints for one lot of undyed PDS II (polydioxanone) Sutures regarding low tensile strength. Internal testing on returned product from this lot confirmed that some PDS II (polydioxanone) Sutures from this lot did not meet the manufacturer’s tensile strength requirement. An investigation identified additional lots across the PDS Plus Antibacterial (polydioxanone) and PDS II (polydioxanone) Suture families that have the potential to be affected by the same root cause as the lot that received the complaints.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 4 Aug 2023