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

Source: https://www.globalkeysolutions.net/records/china_product_recall/ethicon-endo-surgery-llc/4abe3487-600b-44c8-bd5e-365a291fe772/
Source feed: China

> China NMPA product recall for Laparoscopic articular head linear cutting stapler and staple cartridge by Ethicon Endo-Surgery, LLC published June 17, 2013. Recall level: . Ethicon Endo-Surgery, LLC, through its responsible unit in China, Johnson & Johnson (Shanghai) Medic

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Ethicon Endo-Surgery, LLC is recalling its laparoscopic arthroscopic linear stapler and stapler cartridge.
- Company Name: Ethicon Endo-Surgery, LLC
- Publication Date: 2013-06-17
- Product Name: Laparoscopic articular head linear cutting stapler and staple cartridge
- Recall Reason: During firing, there is a possibility of incomplete anastomosis formation due to damage to the staple cartridge. Incomplete anastomosis may lead to inadequate tissue alignment, potentially requiring additional surgical intervention to achieve and maintain the desired alignment.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Ethicon Endo-Surgery, LLC
- Summary: Ethicon Endo-Surgery, LLC, through its responsible unit in China, Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., initiated a global voluntary recall of its Laparoscopic Articular Linear Cutting Stapler and Staple Cartridge (trade name: ECHELON FLEX, model ECR60T) in May 2013. This action was prompted by the potential for staple cartridge damage during firing, which could lead to incomplete anastomosis line formation and insufficient tissue alignment, possibly requiring additional surgical intervention. This notice, published by China's National Medical Products Administration (NMPA) on June 17, 2013, highlights the regulatory oversight of medical devices. While the recall is global, it's important to note that the specific affected product models with expiration dates between May 2013 and March 2014 had not been marketed, imported, or sold within China. Consequently, Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. confirmed that its actions within China would be limited to reporting the recall event to the NMPA. No further in-country investigation, implementation plans, or recall reports would be submitted, as there were no units in the Chinese market to retrieve. The NMPA, for its part, instructed provincial Food and Drug Administrations to enhance supervision and management of such products.

Company: https://www.globalkeysolutions.net/companies/ethicon-endo-surgery-llc/dfce5be3-6a9d-4239-8ba0-5d5283b81a02/