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 Synthes GmbH Cortex Screw Stardrive [Part numbers: 401.766TS, 04.200.018TS] [HKMD number: 170341].
According to the MHRA, a product labeling mix has occurred between the two subject lots of screws. This resulted in incorrect labels being applied to each subject lot.
For further information, please visit: https://mhra-gov.filecamp.com/s/d/yB4E83FojMQFob47
If you are in possession of the affected products, please contact your supplier for necessary actions.
Identified on 05 Apr 2024
Updated on 08 Apr 2024