# China NMPA Product Recall - Hip replacement system

Source: https://www.globalkeysolutions.net/records/china_product_recall/smith-nephew-orthopedics-ltd/e9131613-685e-4ea5-af7b-ef6c19c16e05/
Source feed: China

> China NMPA product recall for Hip replacement system by Smith & Nephew Orthopedics Ltd. published July 04, 2017. Recall level: Level 3. Smith & Nephew Orthopaedics Ltd. initiated a voluntary Class III recall of its hip replacement syste

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Smith & Nephew Orthopaedics Ltd. is issuing a voluntary recall of its hip replacement systems.
- Company Name: Smith & Nephew Orthopedics Ltd.
- Publication Date: 2017-07-04
- Product Name: Hip replacement system
- Recall Level: Level 3
- Recall Reason: Due to problems in the production process, the steel cable was assembled incorrectly, making it impossible to assemble the steel cable onto the implant when using a bent or eccentric acetabular cup implanter.
- Discovering Company: Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Smith & Nephew Orthopedics Ltd.
- Summary: Smith & Nephew Orthopaedics Ltd. initiated a voluntary Class III recall of its hip replacement system, as reported by the National Medical Products Administration (NMPA) on July 4, 2017. The recall was prompted by a manufacturing process error, specifically an incorrect assembly of the steel cable within the hip replacement system. This defect could prevent the cable from being properly attached to the implant, particularly with curved or eccentric acetabular cup components. The recall event form, submitted by Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd., on May 8, 2017, detailed the affected product models and batch numbers (e.g., 74120156, 16FW05491). Under the NMPA framework, a Class III recall indicates a situation where there is a low probability that use of, or exposure to, a violative product will cause adverse health consequences. Crucially, the accompanying report confirmed that the specific affected batches were not distributed or sold within China. Consequently, while a global recall was underway, no direct corrective actions or product retrieval efforts were required for the Chinese market regarding this particular incident.

Company: https://www.globalkeysolutions.net/companies/smith-nephew-orthopedics-ltd/ce4ad0e9-49c1-433f-b695-a82625bda19a/