# China NMPA Product Recall - Hip surgery tool (brand name RECLAIM)

Source: https://www.globalkeysolutions.net/records/china_product_recall/depuy-ireland/5aa04823-4e76-413e-a133-68acbc74fd0a/
Source feed: China

> China NMPA product recall for Hip surgery tool (brand name RECLAIM) by DePuy (Ireland) published October 31, 2014. Recall level: . DePuy (Ireland), a manufacturer, in conjunction with Johnson & Johnson (Shanghai) Medical Devices Co

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Ireland-based DePuy recalls hip surgery tools.
- Company Name: DePuy (Ireland)
- Publication Date: 2014-10-31
- Product Name: Hip surgery tool (brand name RECLAIM)
- Recall Reason: Since 2011, DePuy has received 9 complaints about wing fractures, followed by 37 more complaints related to wing fractures, for a total of 45 complaints related to wing fractures.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: DePuy (Ireland)
- Summary: DePuy (Ireland), a manufacturer, in conjunction with Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., initiated a voluntary recall of its RECLAIM® hip surgery instruments, specifically the distal reamer extension rod (Model/Specification: 2975-00-500). This recall was officially reported to the National Medical Products Administration (NMPA) on October 24, 2014, following an initial corrective notice in March 2013. The primary issue prompting this action was a design flaw leading to fin fractures in the instrument. The company received 9 complaints by 2011, which escalated to 45 related complaints by October 2014. While no fragments were reported remaining in patients, the recurring defect necessitated a comprehensive response. Under the regulatory oversight of the NMPA, the company confirmed that the affected RECLAIM® distal reamer extension rods were not imported or sold within China. Consequently, no direct actions such as product retrieval or patient notifications were required for the Chinese market. The global action involved a redesign of the problematic component to rectify the flaw and a formal replacement initiative for the affected products in markets including Australia, New Zealand, USA, Canada, and various European countries. For China, the required action was limited to reporting the recall to the State Food and Drug Administration, with no further investigation or submission of implementation plans needed due to zero local distribution.

Company: https://www.globalkeysolutions.net/companies/depuy-ireland/00dbdd74-5cb2-4bbd-8581-db4fbb3df9aa/