China NMPA Product Recall - Locking metal bone plate and screw system

Zimmer GmbH, in collaboration with Zimmer (Shanghai) Medical International Trading Co., Ltd., initiated a voluntary Class III recall of its Locking Metal Plate and Screw System. This action, reported to the National Medical Products Administration (NMPA) on June 16, 2022, and publicly announced on June 17, 2022, addresses a significant packaging discrepancy. The core issue involves specific models and batches where NCB self-tapping screws of incorrect sizes were discovered within the product's packaging. The recall targets products with Registration Certificate No.: 20183461997. This proactive measure by Zimmer GmbH aims to maintain product integrity and ensure patient safety by removing non-conforming items from circulation. The NMPA, serving as the overseeing regulatory body, has been duly informed of this event. Further comprehensive details regarding the precise models, specifications, and affected batches are available in the accompanying Medical Device Recall Event Report Form. This recall emphasizes the critical importance of stringent quality control in medical device packaging to prevent potential misuse or complications arising from incorrect component availability, showcasing the company's commitment to regulatory compliance and patient welfare under NMPA's guidance.