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 Biomet, has issued a medical device safety alert concerning its Zimmer Periarticular Locking Plate System, Distal Lateral Femoral Plate Right 6 Holes 159mm Length [Item Number: 00235710106; Lot Number: 64254511, 64296571, 65379087, 65379093, 65379096; UDI Number: (01)0089024055940(10)64254511, (01)0089024055940(10)64296571, (01)0089024055940(10)65379087, (01)0089024055940(10)65379093, (01)0089024055940(10)65379096] [HKMD No.: 160304].
The manufacturer is conducting a lot specific medical device recall due to a possible thread form issue of the locking holes in that the locking screws would 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. The affected devices may have been received as a single finished device or in an instrument kit 00-2358-010-05 Distal Lateral Femoral Plate and Jig Case. According to the manufacturer, it may lead to a loss of fixation, resulting in medical intervention such as revision surgery.
Affected users should identify, quarantine and return the affected product.
According to the local supplier, the affected product is distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 4 Jul 2023