# China NMPA Product Recall - Artificial hip joint, Hip Modular System, Artificial hip joint component

Source: https://www.globalkeysolutions.net/records/china_product_recall/zimmer-medical-shanghai-international-trading-co-ltd/cffaf907-07d8-49b1-9020-5d9aef4e84c1
Source feed: China

> China NMPA product recall for Artificial hip joint, Hip Modular System, Artificial hip joint component by Zimmer Medical (Shanghai) International Trading Co., Ltd. published March 07, 2019. Recall level: Level 2 Recall. On March 7, 2019, Zimmer Medical (Shanghai) International Trading Co., Ltd. initiated a voluntary Cl

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Zimmer Medical (Shanghai) International Trading Co., Ltd. is voluntarily recalling its Hip Modular System (artificial hip joint components).
- Company Name: Zimmer Medical (Shanghai) International Trading Co., Ltd.
- Publication Date: 2019-03-07
- Product Name: Artificial hip joint, Hip Modular System, Artificial hip joint component
- Recall Level: Level 2 Recall
- Recall Reason: Issues involving products where 30mm screws may be packaged as 20mm screws.
- Discovering Company: Zimmer Medical (Shanghai) International Trading Co., Ltd.
- Manufacturing Company: Zimmer Medical (Shanghai) International Trading Co., Ltd.
- Summary: On March 7, 2019, Zimmer Medical (Shanghai) International Trading Co., Ltd. initiated a voluntary Class II recall of its Hip Modular System (Hip Joint Component). This action was taken due to a critical packaging error where 30mm screws were potentially mislabeled or packaged as 20mm screws. The affected products are identified under Registration Certificate Nos.: 20173461073 and 20173462008. The recall was reported through the National Medical Products Administration (NMPA) and involves a medical device registered with the Shanghai Food and Drug Administration. A Class II recall signifies that the product defect could cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. The incorrect sizing of screws in a hip joint component could lead to significant complications for patients, potentially compromising the stability and long-term success of the implant, and necessitating further surgical interventions. This voluntary recall underscores the company's commitment to patient safety and adherence to regulatory standards set by authorities such as the NMPA. Manufacturers are obligated to ensure the accuracy of product specifications and packaging to prevent potential harm to patients. Details regarding specific models, specifications, and batches involved in this recall are provided in the "Medical Device Recall Event Report Form" attached to the official notice, allowing healthcare providers and patients to identify affected components.

Company: https://www.globalkeysolutions.net/companies/zimmer-medical-shanghai-international-trading-co-ltd/22d50256-8f36-4c1a-ba7d-ae035c933119