# China NMPA Product Recall - Hip joint femoral component

Source: https://www.globalkeysolutions.net/records/china_product_recall/microport-orthopedics-inc/22120ad3-3bd0-48c4-b95a-dc5ee5cc1b2c/
Source feed: China

> China NMPA product recall for Hip joint femoral component by Microport Orthopedics, Inc. published March 31, 2021. Recall level: Level 2 Recall. The National Medical Products Administration (NMPA) notice JGXX-2021-10154, published on March 31, 2

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Shanghai Minimally Invasive Orthopedic Medical Technology Co., Ltd. is voluntarily recalling its hip joint femoral component.
- Company Name: Microport Orthopedics, Inc.
- Publication Date: 2021-03-31
- Product Name: Hip joint femoral component
- Recall Level: Level 2 Recall
- Recall Reason: MicroPort Orthopedics Inc. has received complaints of fracture related to the recall of its Profemur split long femoral neck implants. Analysis of potential product-related factors that may have contributed to the risk includes: patient selection factors, surgical technique factors, and design factors.
- Discovering Company: Shanghai Minimally Invasive Orthopedic Medical Technology Co., Ltd.
- Manufacturing Company: Microport Orthopedics, Inc.
- Summary: The National Medical Products Administration (NMPA) notice JGXX-2021-10154, published on March 31, 2021, details a voluntary Class II recall initiated by Shanghai MicroPort Orthopedics Medical Technology Co., Ltd. This action concerns specific hip joint femoral components, manufactured by MicroPort Orthopedics Inc. (Registration Certificate No.: 20173466148).

The recall was prompted by fracture complaints involving the Profemur split long femoral neck. Despite a significantly lower incidence rate in China (0.015%) and Japan (0.009%) compared to the global average (0.55%), the company proceeded with the recall to prevent potential patient harm. An analysis identified product-related factors contributing to the risk, including patient selection, surgical technique, and design elements.

In adherence to regulatory requirements set forth by the NMPA, Shanghai MicroPort Orthopedics Medical Technology Co., Ltd. is undertaking this voluntary recall. While no specific inspection dates were cited, this action underscores the company's commitment to medical device safety standards. Comprehensive details regarding the affected product models, specifications, and batch numbers are provided in an attached Medical Device Recall Event Report Form.

Company: https://www.globalkeysolutions.net/companies/microport-orthopedics-inc/f8c414bb-c564-416c-a346-277a9069d8e6/