# China NMPA Product Recall - Artificial Hip Modular System

Source: https://www.globalkeysolutions.net/records/china_product_recall/biomet-orthopedics/0d0e3f7e-eafe-4c1c-b996-51a5c6622eff/
Source feed: China

> China NMPA product recall for Artificial Hip Modular System by Biomet Orthopedics published January 22, 2020. Recall level: Level 2 Recall. Biomet Orthopedics, in collaboration with Zimmer Medical (Shanghai) International Trading Co., Ltd.,

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Biomet Orthopedics is proactively recalling its Hip Modular System artificial hip joint.
- Company Name: Biomet Orthopedics
- Publication Date: 2020-01-22
- Product Name: Artificial Hip Modular System
- Recall Level: Level 2 Recall
- Recall Reason: Product and label mismatch issue
- Discovering Company: Zimmer Medical (Shanghai) International Trading Co., Ltd.
- Manufacturing Company: Biomet Orthopedics
- Summary: Biomet Orthopedics, in collaboration with Zimmer Medical (Shanghai) International Trading Co., Ltd., initiated a voluntary Class II recall of its Hip Modular System (Registration No. 20173461073). This action, publicized by the National Medical Products Administration (NMPA) on January 22, 2020, addresses a critical product label mismatch issue. The NMPA, operating as the central regulatory authority, supervises medical device recalls to uphold public safety and ensure product integrity within its operational scope. The recall underscores the vital role of precise labeling for medical devices, as discrepancies can lead to incorrect product identification and potential risks to patients. Although specific inspection dates were not detailed in the recall announcement, the prompt reporting by Zimmer Medical signifies a proactive approach to regulatory compliance. The "Medical Device Recall Event Report Form" contains exhaustive information regarding the affected device models, specifications, and batch numbers. Biomet Orthopedics is responsible for implementing this recall, ensuring that all non-compliant products are effectively removed from the supply chain. This event emphasizes the stringent quality control and labeling standards manufacturers must adhere to under the NMPA's regulatory guidelines to maintain patient confidence and safety.

Company: https://www.globalkeysolutions.net/companies/biomet-orthopedics/9bcf230e-90e5-4f4e-8673-6456e0ed8783/