# China NMPA Product Recall - Joint surgical tools

Source: https://www.keypedia.com/records/china_product_recall/howmedicaosteonics-corp/7acdc9e2-4c30-4b32-9f92-73279a8b317a
Source feed: China

> China NMPA product recall for Joint surgical tools by HowmedicaOsteonics Corp. published August 19, 2016. Recall level: Level 3 Recall. The National Medical Products Administration (NMPA) issued a notice on August 19, 2016, detailing a 

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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 within specifications. No adverse patient outcomes were reported.
- Discovering Company: Stryker (Beijing) Medical Devices Co., Ltd.
- Manufacturing Company: HowmedicaOsteonics Corp.
- Summary: The National Medical Products Administration (NMPA) issued a notice on August 19, 2016, detailing a voluntary Class III recall of joint surgical instruments manufactured by Howmedica Osteonics Corp., with Stryker (Beijing) Medical Devices Co., Ltd. acting as the responsible unit in China. This recall stemmed from four reports of component separation within the Scorpio patellar assembly tool. An internal investigation identified that the press-fit between the bone pin and the clamping sub-component failed to meet required specifications. The affected product, a joint surgical instrument registered under CFDA (Imported) No. 20131104042, model 3182-1000, is utilized in various joint repair surgeries. While 55 units were imported and sold in China, no adverse patient consequences were reported. The primary required action involves the return of all affected products to the factory. The initial recall event report was submitted on August 8, 2016, highlighting the manufacturer's proactive response to quality control issues to ensure product reliability and patient safety.

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