China NMPA Product Recall - knee prosthesis

On October 15, 2021, Exactech Medical Devices (Shanghai) Co., Ltd. initiated a voluntary Class III recall of specific knee prostheses. This action, reported by the Shanghai Municipal Drug Administration under the broader oversight of the National Medical Products Administration (NMPA), was prompted by a significant manufacturing oversight by the product's manufacturer, Exactech, Inc. The core issue involved the product packaging, which was found to lack an essential additional oxygen barrier layer, contrary to the specifications detailed in the approved packaging drawings. This deviation from design could potentially compromise the integrity or shelf life of the medical devices. The recall targets products under Registration Certificate No.: 国械注进20173466351. Exactech Medical Devices (Shanghai) Co., Ltd. has made available a "Medical Device Recall Event Report Form" that provides comprehensive details on the affected models, specifications, and batch numbers. This voluntary recall highlights the robust regulatory framework in place to ensure medical device quality and patient safety, mandating that companies proactively address and rectify manufacturing non-conformities through appropriate actions such as recalls.