# China NMPA Product Recall - Hip joint surgical instrument kit

Source: https://www.globalkeysolutions.net/records/china_product_recall/shanghai-minimally-invasive-orthopedic-medical-technology-co-ltd/cf9fec79-d7cb-48fa-bb91-040cf9b1e99e/
Source feed: China

> China NMPA product recall for Hip joint surgical instrument kit by Shanghai Minimally Invasive Orthopedic Medical Technology Co., Ltd. published March 17, 2017. Recall level: Level 2 Recall. On March 17, 2017, the National Medical Products Administration (NMPA) published notice of a volunta

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Shanghai Minimally Invasive Orthopedic Medical Technology Co., Ltd. voluntarily recalls hip joint surgical instrument kits.
- Company Name: Shanghai Minimally Invasive Orthopedic Medical Technology Co., Ltd.
- Publication Date: 2017-03-17
- Product Name: Hip joint surgical instrument kit
- Recall Level: Level 2 Recall
- Recall Reason: The bone file cannot lock properly onto the handle; after forcibly locking the bone file, it cannot disengage from the handle normally.
- Discovering Company: Shanghai Minimally Invasive Orthopedic Medical Technology Co., Ltd.
- Manufacturing Company: Shanghai Minimally Invasive Orthopedic Medical Technology Co., Ltd.
- Summary: On March 17, 2017, the National Medical Products Administration (NMPA) published notice of a voluntary Level II recall initiated by Shanghai Minimally Invasive Orthopedic Medical Technology Co., Ltd. This recall pertains to the company's Hip Joint Surgical Instrument Kit due to a significant functional defect identified post-market. The core issue involves the bone reamer component within the kit, which was found to have two critical flaws: it could not be properly secured or locked onto its designated handle, and if forcibly engaged, it subsequently became impossible to detach from the handle as intended. Such a malfunction in a surgical instrument poses considerable risks, potentially disrupting critical medical procedures and compromising patient safety. Recognizing the seriousness of this defect, Shanghai Minimally Invasive Orthopedic Medical Technology Co., Ltd. promptly decided to execute a voluntary recall for all affected products. This action underscores the company's adherence to product quality standards and its responsibility to medical professionals and patients. The regulatory framework for this recall falls under the NMPA's oversight, ensuring that medical devices meet stringent safety and efficacy requirements in China. Further detailed information, including specific models, specifications, and batch numbers of the recalled instruments, is officially documented in the "Medical Device Recall Event Report Form," accessible through the NMPA.

Company: https://www.globalkeysolutions.net/companies/shanghai-minimally-invasive-orthopedic-medical-technology-co-ltd/8c61a790-072a-4ccd-b907-8769f72c1fa8/