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 States Food and Drug Administration (FDA) has posted a medical device safety alert concerning Synthes (USA) Products LLC TFN-Advanced Femoral Nail [HKMD No.: 180279]. The affected devices are identified as the following:
According to the FDA, the manufacturer is advising that TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nails labeled and etched as 170mm may measure 200mm in length
For further information, please visit https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=91702
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 13 Mar 2023