China NMPA Product Recall - knee prosthesis
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The National Medical Products Administration (NMPA) has announced a voluntary Class III recall initiated by Zimmer Inc., a medical device manufacturer, concerning specific batches of knee prostheses. This recall, reported by Zimmer (Shanghai) Medical International Trading Co., Ltd., was prompted by the discovery of incorrect labeling on a particular batch of these medical devices. The official notice, identified as NMPA Index No. JGXX-2023-10094, was published on June 1, 2023, highlighting the regulatory body's role in overseeing product safety and compliance within the medical industry. While the document does not specify inspection dates, the voluntary nature of the recall underscores Zimmer Inc.'s proactive approach to address the labeling discrepancy. The affected products' detailed models, specifications, and batch numbers are available in an accompanying 'Medical Device Recall Event Report Form,' which is accessible through Zimmer Medical (Shanghai) International Medical Trading Co., Ltd. This action ensures that all distributed products meet the required labeling standards and reinforces the commitment to maintaining product integrity and patient safety under the NMPA's regulatory framework.
- Company
- Zimmer Dental Inc. (USA)
ID · 90747616-010e-4aa5-b170-907fd38853a3