# China NMPA Product Recall - Knee prostheses, patellar components

Source: https://www.globalkeysolutions.net/records/china_product_recall/howmedicaosteonics-corp/2ab48f21-d704-4a6e-8e43-2ec66dd0f20c/
Source feed: China

> China NMPA product recall for Knee prostheses, patellar components by HowmedicaOsteonics Corp. published September 19, 2019. Recall level: Level 2 Recall. Howmedica Osteonics Corp., a manufacturer of medical devices, initiated a voluntary Class II recall 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Howmedica Osteonics Corp. is voluntarily recalling knee prostheses and patellar components.
- Company Name: HowmedicaOsteonics Corp.
- Publication Date: 2019-09-19
- Product Name: Knee prostheses, patellar components
- Recall Level: Level 2 Recall
- Recall Reason: There may be issues with the packaging of certain batches of products being exposed to water and/or steam.
- Discovering Company: Stryker (Beijing) Medical Devices Co., Ltd.
- Manufacturing Company: HowmedicaOsteonics Corp.
- Summary: Howmedica Osteonics Corp., a manufacturer of medical devices, initiated a voluntary Class II recall of specific batches of knee prostheses and patellar components. The National Medical Products Administration (NMPA) published this information on September 19, 2019. The recall was reported by Stryker (Beijing) Medical Devices Co., Ltd., and stems from a potential issue where the packaging of these medical devices may have been compromised by contamination with water and/or steam. This contamination could affect product sterility or integrity. The affected products include knee prostheses (Registration Certificate No.: 20193132104) and patellar components (Registration Certificate No.: 20183130388). The specific models, specifications, and batch numbers subject to the recall are detailed in the accompanying "Medical Device Recall Event Report Form" attachment, which outlines the required actions for addressing this packaging deficiency.

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