China NMPA Product Recall - Hip prosthesis - Dual Mobility Vivacit-E Polyethylene Hip Bearing

Zimmer Inc., a U.S.-based medical device manufacturer, in conjunction with its subsidiary Zimmer (Shanghai) Medical International Trading Co., Ltd., has initiated a voluntary recall of its Dual Mobility Vivacit-E Polyethylene Hip Bearing. This recall, affecting 44mm and 46mm VIVACIT-E VE antioxidant high cross-linked polyethylene dual motion acetabular liners, has been classified as a Class III event by the National Medical Products Administration (NMPA), China's key regulatory authority for medical devices. The official recall notification, with an index number JGXX-2025-10147, was published on October 21, 2025, by the NMPA. While the specific reasons leading to this voluntary recall are not detailed within the public notice, the company has submitted a comprehensive "Medical Device Recall Event Report Form." This form, alongside a specific report from Zimmer (Shanghai), contains the full product models, specifications, packaging information, and the detailed scope of the recall. The provided document does not specify any inspection dates related to this event, focusing instead on the company's proactive recall action under the NMPA's oversight. The primary required action by the company is the execution of this voluntary recall, with the specifics of product handling and remediation outlined in the attached reports, ensuring compliance with NMPA regulations.