# China NMPA Product Recall - Joint surgical tools

Source: https://www.globalkeysolutions.net/records/china_product_recall/howmedicaosteonics-corp/f40278f0-d17e-4f26-ac4a-628a381a722c/
Source feed: China

> China NMPA product recall for Joint surgical tools by HowmedicaOsteonics Corp. published July 20, 2016. Recall level: . The National Medical Products Administration (NMPA) announced a recall initiated by Howmedica Osteon

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Howmedica Osteonics Corp. recalls joint surgery tools.
- Company Name: HowmedicaOsteonics Corp.
- Publication Date: 2016-07-20
- Product Name: Joint surgical tools
- Recall Reason: A study of the two finished products of the assembled handle showed that the supplier did not fully meet the press-fit parameters between the fixed pin and the pin hole on the shaft, which could potentially cause the tools to separate.
- Discovering Company: Stryker (Beijing) Medical Devices Co., Ltd.
- Manufacturing Company: HowmedicaOsteonics Corp.
- Summary: The National Medical Products Administration (NMPA) announced a recall initiated by Howmedica Osteonics Corp. for joint surgical instruments, distributed in China by Stryker (Beijing) Medical Devices Co., Ltd. The recall, reported on June 29, 2016, and published on July 20, 2016, addresses a manufacturing defect. The primary concern stems from a potential issue with the connection between the fixing pin and the pin hole on the instrument's shaft. Investigations revealed that the supplier's press-fit parameters for these components did not meet required standards, which could lead to the tools separating during surgical procedures. These instruments are vital for various arthroplasty and trauma surgeries. While the recall impacted multiple countries globally, including the USA, Canada, and Japan, Stryker (Beijing) confirmed that no affected products were imported into or sold within China. Therefore, the Chinese distributor stated that, beyond reporting the incident to the State Food and Drug Administration (CFDA, predecessor to NMPA), no further direct action would be undertaken in China. The NMPA, operating under its regulatory framework, has urged provincial drug administrations to enhance their supervision of such products to ensure continued safety.

Company: https://www.globalkeysolutions.net/companies/howmedicaosteonics-corp/fb8e59ba-c29a-43ec-b211-2e0a543aa1f7/