# China NMPA Product Recall - Hip joint prosthesis components (trade name: Charnley)

Source: https://www.globalkeysolutions.net/records/china_product_recall/depuy-international-ltd-depuy-orthopedics-inc/daf1a3ec-d234-4029-aab3-b3723fc9f4e4/
Source feed: China

> China NMPA product recall for Hip joint prosthesis components (trade name: Charnley) by DePuy International, Ltd, DePuy Orthopedics, Inc published February 22, 2011. Recall level: . The National Medical Products Administration (NMPA) announced a significant product recall initiated

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: DePuy International, Ltd., DePuy Orthopaedics, Inc. is recalling hip prosthesis components (trade name: Charnley).
- Company Name: DePuy International, Ltd, DePuy Orthopedics, Inc
- Publication Date: 2011-02-22
- Product Name: Hip joint prosthesis components (trade name: Charnley)
- Recall Reason: Errors during the production process may result in incomplete sealing of the product's outer packaging.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: DePuy International, Ltd, DePuy Orthopedics, Inc
- Summary: The National Medical Products Administration (NMPA) announced a significant product recall initiated by DePuy International, Ltd., and DePuy Orthopaedics, Inc., concerning their Charnley brand hip prosthetic components. This voluntary recall, initially reported by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., on February 14, 2011, and publicly disclosed by the NMPA on February 22, 2011, addresses a critical quality concern. The primary issue identified was a manufacturing error leading to potentially incomplete sealing of the product's outer packaging bags. This defect poses a risk to the sterility and overall integrity of the medical device, which is essential for patient safety during hip replacement procedures. The affected products, registered under CFDA (Imported) No. 2007 3461391, were subject to a global recall, although specific details for the Chinese market indicated one unit was affected. Operating under the NMPA's regulatory framework, the immediate required action for the responsible units was to swiftly recall all affected hip prosthetic components from the Chinese market. This proactive measure aims to prevent the use of potentially compromised devices and uphold the high standards of medical product safety and efficacy.

Company: https://www.globalkeysolutions.net/companies/depuy-international-ltd-depuy-orthopedics-inc/08727976-15c1-4cd2-ab57-da3aa7e554a7/