# China NMPA Product Recall - Rotating hinge type knee joint system (trade name: S-Rom Noiles)

Source: https://www.globalkeysolutions.net/records/china_product_recall/depuy-orthopaedics-inc/a2839c31-4379-476f-a0f4-cc4ffba22435/
Source feed: China

> China NMPA product recall for Rotating hinge type knee joint system (trade name: S-Rom Noiles) by DePuy Orthopaedics, Inc. published April 04, 2014. Recall level: . On April 4, 2014, the National Medical Products Administration (NMPA) announced a voluntary recall i

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Deputy Orthopaedics, Inc. of the United States has issued a recall for its rotary hinge knee system.
- Company Name: DePuy Orthopaedics, Inc.
- Publication Date: 2014-04-04
- Product Name: Rotating hinge type knee joint system (trade name: S-Rom Noiles)
- Recall Reason: Between 1999 and 2013, DePuy received 45 reports of holes in one or two sterile bags. The complaint rate between 2010 and 2013 was 0.35%. We believe the holes were caused by repeated shipments of the product over several years.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: DePuy Orthopaedics, Inc.
- Summary: On April 4, 2014, the National Medical Products Administration (NMPA) announced a voluntary recall initiated by DePuy Orthopaedics, Inc. (USA) for its Rotary Hinge Knee Joint Systems (S-Rom Noiles). The recall was reported to the NMPA by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., the distributor in China. The primary issue involved 45 reports, received between 1999 and 2013, detailing holes found in the sterile bags of the product. This packaging defect, with a complaint rate of 0.35% from 2010-2013, was attributed to damage sustained during repeated shipments over several years, potentially compromising product sterility.

Operating under the NMPA's regulatory oversight, the recall was global, affecting numerous countries. However, Johnson & Johnson (Shanghai) explicitly confirmed that the specific batch numbers identified as problematic were not imported into China. Therefore, while the situation was reported to the NMPA, no further direct actions, such as investigations or implementation plans, were deemed necessary or taken for the Chinese market. The NMPA subsequently instructed provincial and local food and drug administrations to strengthen general supervision and management concerning medical devices.

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