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 United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has posted a medical device safety alert concerning Smith & Nephew Inc., Endoscopy Division REGENETEN Tendon Anchors (8) [Product No.: 2504-1, 72205201; Unique Device Identifier(s): 00854501006067, 00885556733486] [HKMD No.: 230374].
According to the MHRA, the manufacturer has initiated a field action to voluntarily remove multiple lots of the REGENETEN Tendon Anchors (8). There is a potential for a sterile barrier breach due to a packaging issue. Specifically, an issue identified in the product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding the inner Tyvek pouch, which contains the sterile product. As a result of the breached foil pouch, the sterile field may be contaminated by the outside of the inner pouch.
For further information, please visit: https://mhra-gov.filecamp.com/s/d/tTh0GLP6gFHFORA0
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 20 Aug 2024