# China NMPA Product Recall - Joint surgical tools

Source: https://www.globalkeysolutions.net/records/china_product_recall/howmedicaosteonics-corp/9f6d9422-d542-4efe-8710-7bac8f1a65b1/
Source feed: China

> China NMPA product recall for Joint surgical tools by HowmedicaOsteonics Corp. published August 19, 2016. Recall level: Level 3 Recall. Howmedica Osteonics Corp., in collaboration with its Chinese responsible unit, Stryker (Beijing) Med

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Howmedica Osteonics Corp. initiates voluntary recall of joint surgery tools.
- Company Name: HowmedicaOsteonics Corp.
- Publication Date: 2016-08-19
- Product Name: Joint surgical tools
- Recall Level: Level 3 Recall
- Recall Reason: The factory received four reports of component separation from the Scorpio patellar assembly tool. Investigation revealed that the press-fit parameters between the bone pin and the clamping sub-component were not in compliance with specifications. No adverse patient outcomes were reported.
- Discovering Company: Stryker (Beijing) Medical Devices Co., Ltd.
- Manufacturing Company: HowmedicaOsteonics Corp.
- Summary: Howmedica Osteonics Corp., in collaboration with its Chinese responsible unit, Stryker (Beijing) Medical Devices Co., Ltd., initiated a voluntary recall of specific joint surgical tools. This action was reported by the company on August 8, 2016, and publicly announced by the National Medical Products Administration (NMPA) on August 19, 2016. The recall was prompted by four reports of component separation in the Scorpio patellar assembly tool. Investigations determined that the press-fit between the bone pin and the clamping sub-component did not adhere to manufacturing specifications. These surgical instruments are utilized in various joint repair procedures, including hip, knee, and shoulder surgeries. Although the manufacturing defect was identified, no adverse patient consequences have been reported. Under the regulatory oversight of the NMPA, all affected products, which were imported under CFDA approval, are being returned to the factory as a corrective measure.

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