# China NMPA Product Recall - Joint surgery instrument pack

Source: https://www.globalkeysolutions.net/records/china_product_recall/microport-orthopedics-inc/7e2e2eac-aa9b-449a-a5b7-a1edab26780e/
Source feed: China

> China NMPA product recall for Joint surgery instrument pack by Microport Orthopedics, Inc. published March 17, 2017. Recall level: Level 2 Recall. Shanghai Minimally Invasive Orthopedic Medical Technology Co., Ltd., under the regulatory oversight 

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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: Joint surgery instrument pack
- Recall Level: Level 2 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., under the regulatory oversight of the National Medical Products Administration (NMPA), initiated a voluntary Level II recall for a Hip Joint Surgical Instrument Kit. The recall, publicly reported on March 17, 2017, was prompted by a significant functional defect. It was discovered that the bone reamer, a component within the affected product (specifically, the PPW38078 Quick-Release Handle, batch US100122), could not be properly secured to its handle. Furthermore, if forcibly attached, the reamer could not be properly detached, posing a critical issue for surgical use. The manufacturer, Microport Orthopedics, Inc., identified three units of this problematic batch that had been imported into China. As a corrective action, all three affected units were returned to the United States in September 2016. Consequently, as no products from the identified batch remained in the Chinese market at the time of the recall report, no further actions were required within China. The recall also impacted regions including Spain and Italy.

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