China NMPA Product Recall - Hip Joint Prostheses-Acetabular System

Zimmer GmbH has initiated a voluntary Class II recall of its Hip Joint Prostheses-Acetabular System. This action, reported by Zimmer (Shanghai) Medical International Trading Co., Ltd., stems from a potential risk of bubble packaging deformation, which could compromise product integrity. The recall pertains to products under Registration Certificate No.: 20173466495. The National Medical Products Administration (NMPA) published this recall on July 30, 2019. The regulatory framework for this action falls under the NMPA's medical device recall guidelines, classifying it as Class II, indicating a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. Specific models, specifications, and batch numbers of the affected devices are detailed in an accompanying Medical Device Recall Event Report Form. The required action for the company is to execute the voluntary recall of the impacted hip joint prostheses to address the identified packaging issue.