# China NMPA Product Recall - Hip joint surface replacement system

Source: https://www.globalkeysolutions.net/records/china_product_recall/depuy-international-ltd/255f8600-174b-42b9-ad67-d5e0bec34413/
Source feed: China

> China NMPA product recall for Hip joint surface replacement system by DePuy International Ltd. published August 31, 2010. Recall level: . This document, an NMPA Medical Device Recall Event Report Form, details a voluntary recall initiated

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Recall Event Report Form for Hip Resurfacing Replacement Systems
- Company Name: DePuy International Ltd.
- Publication Date: 2010-08-31
- Product Name: Hip joint surface replacement system
- Recall Reason: Recent data received by DePuy shows that the five-year revision rate for the ASR™ hip resurfacing system and the ASR™ XL metal-to-metal total hip system is higher than expected. Female patients using ASR femoral head prostheses with a diameter of less than 50 mm have the highest revision risk, so a voluntary recall has been initiated.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: DePuy International Ltd.
- Summary: This document, an NMPA Medical Device Recall Event Report Form, details a voluntary recall initiated by DePuy International, Ltd, with its Chinese responsible unit being Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. The report, dated August 24, 2010, and published on August 31, 2010, concerns their Hip Joint Resurfacing System, specifically the ASR™ Acid Resurfacing System and ASR™ XL Metal-to-Metal Full-Ground System.
The primary issue prompting the recall is new data from the National Joint Registry (NJR) in England and Wales. This data revealed a higher-than-expected five-year revision rate for these hip systems: approximately 12% for the ASR™ Acid Resurfacing System and 13% for the ASR™ XL Metal-to-Metal Full-Ground System. A particular concern was identified for female patients receiving ASR femoral head prostheses with a diameter less than 50 mm, who faced the highest risk of revision.
Operating under the oversight of the National Medical Products Administration (NMPA) in China, DePuy decided to execute a global voluntary recall for all affected ASR/ASR products. The required actions included notifying all users of the DePuy Hip Replacement System and managing the recall of 12,166 affected units imported into China, of which 11,522 had been sold. This swift action aims to address the safety concerns highlighted by the updated performance data.

Company: https://www.globalkeysolutions.net/companies/depuy-international-ltd/3080c135-e69a-4189-a1de-22181dbca926/