# China NMPA Product Recall - Laparoscopic linear cutting stapler and staple cartridge

Source: https://www.globalkeysolutions.net/records/china_product_recall/johnson-johnson-shanghai-medical-devices-co-ltd/a5c35480-2bef-4029-a66c-e4b97beaee38/
Source feed: China

> China NMPA product recall for Laparoscopic linear cutting stapler and staple cartridge by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. published May 08, 2017. Recall level: Level II. Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. has initiated a voluntary Class II recall con

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. is voluntarily recalling its laparoscopic linear stapler and staple cartridge.
- Company Name: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Publication Date: 2017-05-08
- Product Name: Laparoscopic linear cutting stapler and staple cartridge
- Recall Level: Level II
- Recall Reason: During the production process, the company discovered a quality problem with a component through its quality control procedures and believed that the mechanical gear assembly might be at risk of failure under extreme usage conditions.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Summary: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. has initiated a voluntary Class II recall concerning its Laparoscopic Linear Cutting Anastomosing Device and Staple Cartridge. The company proactively identified a critical quality issue in a component during its routine production and quality control procedures. This defect specifically pertains to the device's gear mechanism, which analysis indicates may fail under extreme operational conditions, potentially compromising the device's intended function and patient safety. The decision to conduct this recall, categorized as Class II, underscores the company's commitment to product quality and regulatory compliance. This action, publicly announced on May 8, 2017, falls under the oversight and regulatory framework of the National Medical Products Administration (NMPA) in China, which governs medical device safety and recalls. While no specific inspection dates were provided, the issue was internally discovered during manufacturing. The required action involves the removal of affected products from the market. Comprehensive details, including the specific models, specifications, and batch numbers of the impacted devices, are fully documented in the accompanying "Medical Device Recall Event Report Form." This ensures transparent communication and facilitates the necessary corrective measures to address the identified quality concern.

Company: https://www.globalkeysolutions.net/companies/johnson-johnson-shanghai-medical-devices-co-ltd/c552b533-9bb4-43a8-858a-e58faf1dd14e/