China NMPA Product Recall - Knee components

Zimmer Medical (Shanghai) International Trading Co., Ltd. initiated a voluntary Class II recall of specific knee joint components, as announced by the National Medical Products Administration (NMPA) on May 8, 2017. The company identified a significant quality concern for products manufactured between December 2016 and February 2017, discovering that these devices might contain potentially excessive endotoxin levels. Such elevated levels could present a health risk to patients upon implantation, necessitating immediate corrective action.

Operating under the regulatory framework of the NMPA, Zimmer Medical proactively decided to withdraw all affected products from the market. Detailed information regarding the precise models, specifications, and batch numbers subject to this recall is available in the associated "Medical Device Recall Event Report Form." The required actions for the company involve the systematic identification, quarantine, and removal of these non-conforming knee joint components to ensure patient safety and maintain compliance with established medical device quality standards. This measure underscores the company's commitment to addressing product quality deviations promptly and effectively within the NMPA's oversight.