China NMPA Product Recall - Metal plate fixation system

Stryker GmbH, in collaboration with its subsidiary Stryker (Beijing) Medical Devices Co., Ltd., initiated a voluntary Class III recall of specific batches of its Metal Bone Plate Fixation System. This action, reported to the National Medical Products Administration (NMPA) on June 27, 2017, and publicly announced on September 27, 2017, was prompted by a manufacturing defect. The primary issue involved the presence of metal burrs within the core of the tension screws, which obstructed the passage of a guide wire. This defect rendered the device potentially non-functional for its intended purpose of temporary fixation of fractures and bone fragments. Affected product models included 33625110 (batch V06279) and 33625105 (batch V06269), under National Medical Device Registration Certificate 20163461622. The regulatory framework for this action falls under NMPA guidelines for medical device recalls. Stryker's required actions included retrieving the affected products and formally reporting the incident to the State Food and Drug Administration. While a customer complaint led to the discovery, no patient injuries were reported. This recall underscored the manufacturer's commitment to product quality and patient safety within its global distribution network.