China NMPA Product Recall - Dental implants

On June 12, 2019, the National Medical Products Administration (NMPA) announced a Class II voluntary recall initiated by Zimmer Dental Inc. This recall pertains to certain dental implants manufactured by Zimmer Dental Inc. and reported by its Chinese subsidiary, Zimmer Dental Inc. (Shanghai) Medical Device Co., Ltd. The primary reason for the recall is a potential issue involving broken bottle caps associated with the product packaging. This concern affects the integrity of the product and prompted the manufacturer to take corrective action. The recall operates under the regulatory framework overseen by the NMPA, referencing Registration Certificate No.: CFDA (Imported) 2014 (Updated). As a required action, Zimmer Dental Inc. is voluntarily removing the affected dental implants from the market. Comprehensive details regarding the specific models, specifications, and batch numbers of the impacted devices are documented in the accompanying "Medical Device Recall Event Report Form," which serves as the official record of the recall event. This proactive measure aims to address the identified quality issue and ensure patient safety regarding these imported medical devices.