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, Zimmer Inc., has issued a medical device safety alert concerning its Zimmer Periarticular Locking Plate System and Distal Lateral Fibula Locking Plate products (2357-017 and 2357-018 families) [HKMD Number: 160304].
According to the manufacturer, this recall is due to a possible thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock. There are no specific patient monitoring instructions recommended beyond the existing follow-up schedule for previously implanted products
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 26 Mar 2024