# China NMPA Product Recall - Hip joint surgical instruments (product name: RECLAIM)

Source: https://www.globalkeysolutions.net/records/china_product_recall/depuy-ireland/2fa5dcc3-fc84-4d77-bfee-a86d92be36cf/
Source feed: China

> China NMPA product recall for Hip joint surgical instruments (product name: RECLAIM) by DePuy (Ireland) published May 04, 2015. Recall level: . Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., acting on behalf of manufacturer DePuy (Irel

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Ireland's DePuy is recalling its hip surgery tool (brand name: RECLAIM).
- Company Name: DePuy (Ireland)
- Publication Date: 2015-05-04
- Product Name: Hip joint surgical instruments (product name: RECLAIM)
- Recall Reason: On February 6, 2015, the manufacturer received a complaint regarding the breakage of a specific batch of the prosthesis implant adapter (model: 2975-00-920) from the RECLAIM hip surgery tool (trade name: RECLAIM) during implantation of the prosthesis stem. The complaint stated that all broken parts had been removed from the patient without causing any harm. The manufacturer conducted an investigation and confirmed the possibility that the device could break and leave fragments inside the patient during impact.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: DePuy (Ireland)
- Summary: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., acting on behalf of manufacturer DePuy (Ireland), initiated a voluntary recall for the RECLAIM hip surgical instrument (Registration Certificate No.: CFDA (Imported) 2014 No. 1100752). This action was publicly noted by the National Medical Products Administration (NMPA) on May 4, 2015, following a complaint received on February 6, 2015. The primary concern was the potential for the prosthesis implant adapter (model: 2975-00-920) to break during hip replacement surgery, potentially leaving fragments within the patient. An investigation corroborated this risk. Under the NMPA's regulatory framework, Johnson & Johnson (Shanghai) reported the incident. Crucially, the affected product batches were neither imported into nor sold within China, with distribution limited to regions such as Ireland, Iceland, and the USA. Consequently, no further specific corrective actions, such as additional investigations or implementation plans, were required from Johnson & Johnson (Shanghai) within China. However, the NMPA requested that provincial food and drug administrations strengthen their oversight and management of similar medical devices.

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