# China NMPA Product Recall - Hip joint surgical instrument kit

Source: https://www.globalkeysolutions.net/records/china_product_recall/microport-orthopedics-inc/fd9bbce9-5027-470c-a158-15519dc3623b/
Source feed: China

> China NMPA product recall for Hip joint surgical instrument kit by Microport Orthopedics, Inc. published March 17, 2017. Recall level: Class II Recall. Shanghai Minimally Invasive Orthopedic Medical Technology Co., Ltd. initiated a voluntary Level II r

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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: Microport Orthopedics, Inc.
- Publication Date: 2017-03-17
- Product Name: Hip joint surgical instrument kit
- Recall Level: Class II Recall
- Recall Reason: 1) The bone file cannot lock properly onto the handle. 2) After forcibly locking the bone file, it cannot disengage properly from the handle.
- Discovering Company: Shanghai Minimally Invasive Orthopedic Medical Technology Co., Ltd.
- Manufacturing Company: Microport Orthopedics, Inc.
- Summary: Shanghai Minimally Invasive Orthopedic Medical Technology Co., Ltd. initiated a voluntary Level II recall of its Hip Joint Surgical Instrument Kit, specifically involving the PPW38078 Quick-Release Handle with batch number US100122. This action, reported to the National Medical Products Administration (NMPA) on February 1, 2017, and published on March 17, 2017, addresses a critical product malfunction. The primary issue identified was that the bone reamer within the affected product failed to properly lock onto its handle. Furthermore, if forcibly locked, the reamer could not be safely detached, posing significant risks during surgical procedures. The company's corrective actions aim to resolve these locking and detachment failures. Although three units of the affected product were imported into China, they were subsequently returned to the United States in September 2016, and no units from the problematic batch were sold or remained in China. The recall primarily impacts regions such as Spain and Italy, where the product may have been distributed. This proactive recall demonstrates the company's commitment to product safety and compliance with medical device regulations under the NMPA framework.

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