China NMPA Product Recall - Artificial Hip Joint
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The National Medical Products Administration (NMPA) announced on March 14, 2023, that Biomet Orthopedics has initiated a voluntary Class III recall of specific models and batches of its artificial hip joints. This action was reported by Zimmer Medical (Shanghai) International Trading Co., Ltd. The primary reason for the recall is an incorrect labeling issue identified on certain products. The recall pertains to artificial hip joints, specifically identified by registration number 20153463499. The NMPA's involvement highlights its role in overseeing medical device safety and ensuring manufacturers and distributors adhere to regulatory standards for product quality and labeling. A Class III recall indicates that the use of or exposure to a violative product is not likely to cause adverse health consequences. While the document does not specify inspection dates, the NMPA's publication date marks the official public notification of the recall. Affected product details, including models, specifications, and batch numbers, are further elaborated in an accompanying 'Medical Device Recall Event Report Form,' which provides comprehensive information for stakeholders regarding the necessary actions and scope of the recall. This proactive measure by Biomet Orthopedics, facilitated through Zimmer Medical, underscores a commitment to patient safety and regulatory compliance.
- Company
- Biomet Orthopedics
ID · 36d593dd-576c-43c0-b8cc-d74d4463f3ac