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 Stryker Spine, Inc AVS Anchor-C Cervical Cage System [HKMD No.: 160167].
According to the FDA, Labeling Correction: Instructions For Use (IFU)-Updated electronic Rev 5, specific language for indications for use for the United States and Canada was inadvertently removed.
For further information, please visit: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=95274
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 26 Sep 2024