# China NMPA Product Recall - Hip joint femoral neck component

Source: https://www.globalkeysolutions.net/records/china_product_recall/microport-orthopedics-inc/0671d471-38aa-4985-983b-44e9c52ced41/
Source feed: China

> China NMPA product recall for Hip joint femoral neck component by Microport Orthopedics, Inc. published August 12, 2015. Recall level: Class II Recall. The National Medical Products Administration (NMPA) issued a recall notice on August 12, 2015, conce

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Shanghai Minimally Invasive Orthopedic Medical Technology Co., Ltd. voluntarily recalls hip joint bone and neck components.
- Company Name: Microport Orthopedics, Inc.
- Publication Date: 2015-08-12
- Product Name: Hip joint femoral neck component
- Recall Level: Class II Recall
- Recall Reason: The affected products have a higher rate of femoral neck fractures than other models and specifications, and this defect cannot be identified by visual inspection or other preoperative methods, posing a potential risk of harm to patients.
- Discovering Company: Shanghai Minimally Invasive Orthopedic Medical Technology Co., Ltd.
- Manufacturing Company: Microport Orthopedics, Inc.
- Summary: The National Medical Products Administration (NMPA) issued a recall notice on August 12, 2015, concerning a voluntary recall initiated by Microport Orthopedics, Inc., with its responsible unit in China, Shanghai Minimally Invasive Orthopedic Medical Technology Co., Ltd. The recall pertains to the Hip Joint Femoral Neck Component, specifically model PHAC1254, 8
 Varus.The primary issue identified was an unexpectedly higher rate of femoral neck fractures in the affected product compared to other models. This critical defect could not be detected through visual inspection or other preoperative assessment methods, posing a potential risk to patients undergoing total hip arthroplasty. A total of 185 units were affected globally, with 164 units sold in China across all batches.Under the NMPA's regulatory oversight, the company initiated a Class II recall. The required corrective actions included immediately instructing distributors to cease sales of the identified product and actively recalling all affected units from the market based on product traceability information to prevent potential patient harm and ensure public safety.

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