China NMPA Product Recall - Hip Components - Bipolar Head Hip Components; Shoulder Surgical Instruments; Hip Surgical Instruments; Inverted Shoulder Joint System; Non-Absorbable Ligament Fixation Screws; Artificial Hip Joint; Knee Joint

Zimmer Medical (Shanghai) International Trading Co., Ltd., an affiliate of Zimmer Biomet, initiated a voluntary Class II recall of several medical devices, as announced by the Shanghai Drug Administration on December 2, 2020 (Recall No. 2020-245). The recall addresses a critical product safety concern where the sterile barrier of affected products might be compromised due to impaired sealing in supplier-provided packaging. The recall impacts a range of hip, knee, and shoulder joint components, including Bipolar Head Hip Components, Shoulder Surgical Instruments, Hip Surgical Instruments, Inverted Shoulder Joint Systems, Non-Absorbable Ligament Fixation Screws, and Artificial Hip Modular Systems. These products are identified by specific registration numbers, such as 20153133783 and 20193130538, and associated batches. This action falls under the regulatory oversight of the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration. Zimmer Medical is required to follow established protocols for Class II recalls, ensuring proper identification and retrieval of all affected products from the market. Further details regarding specific models and batches are documented in the "Medical Device Recall Event Report Form," which stakeholders are encouraged to consult for comprehensive information. This proactive measure aims to mitigate potential risks to patient safety posed by non-sterile medical devices.