# China NMPA Product Recall - Knee joint surgical tools

Source: https://www.globalkeysolutions.net/records/china_product_recall/depuy-orthopaedics-inc/d162d17d-eac7-4461-b014-5eb55724388c/
Source feed: China

> China NMPA product recall for Knee joint surgical tools by DePuy Orthopaedics, Inc. published September 29, 2015. Recall level: Level II. Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., on behalf of manufacturer DePuy Orthopaedics

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. voluntarily recalls knee surgery tools
- Company Name: DePuy Orthopaedics, Inc.
- Publication Date: 2015-09-29
- Product Name: Knee joint surgical tools
- Recall Level: Level II
- Recall Reason: The manufacturer has received complaints regarding the affected product, alleging that the rod has broken and a portion remains inside the patient. The manufacturer has confirmed that the affected product may fail due to fatigue and/or overload under excessive force. The rod tip has a deep J-groove, a structure used in revision cases to lock the sleeve in place; breakage may have occurred within this groove. If observed intraoperatively, attempting to remove the remaining rod could lead to significant surgical delay and minor bone damage. If not observed intraoperatively, it could cause bone remodeling and inflammation, resulting in adverse tissue reactions, and may also cause pain during MRI due to potential bone remodeling. These clinical effects may necessitate revision surgery. Two adverse events have been reported in China.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: DePuy Orthopaedics, Inc.
- Summary: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., on behalf of manufacturer DePuy Orthopaedics, Inc., initiated a voluntary Class II recall of specific Knee Joint Surgical Instruments, as announced by the National Medical Products Administration (NMPA) on September 29, 2015. The recall was prompted by the discovery that the SP2 intramedullary rod, a critical component within these instruments, is prone to fracture under fatigue or excessive torque, particularly at a deep J-groove near its tip. This structural defect presents several significant clinical risks.

The primary issues include the potential for surgical delays and minor bone damage if a fracture is detected during knee replacement surgery. If the breakage remains undetected intraoperatively, it can lead to more severe complications such as bone remodeling, inflammation, adverse tissue reactions, and pain during magnetic resonance imaging (MRI), often necessitating subsequent revision surgery for patients. Two adverse events related to these fractures had been reported in China prior to the recall.

In response, Johnson & Johnson implemented required corrective actions, which involved immediately notifying all affected customers to discontinue using the implicated products and to contact Johnson Medical. Additionally, all identified affected products—including 73 consigned units and 58 units in stock within China (none had been sold)—were slated for local destruction. This global recall action, encompassing various identified batch numbers, underscores the company's commitment to product safety under the NMPA's regulatory oversight.

Company: https://www.globalkeysolutions.net/companies/depuy-orthopaedics-inc/abe8ff95-754c-4e38-898b-9df32f104a7a/