# China NMPA Product Recall - Bone power systems, orthopedic tools and accessories

Source: https://www.globalkeysolutions.net/records/china_product_recall/stryker-instruments/b47a214e-0f39-44fa-8091-80147c62c129/
Source feed: China

> China NMPA product recall for Bone power systems, orthopedic tools and accessories by Stryker Instruments published July 14, 2023. Recall level: Level 3 Recall. On July 14, 2023, Stryker Instruments, through its subsidiary Stryker (Beijing) Medical Devices Co.,

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Stryker Instruments initiates voluntary recall of bone power systems and orthopedic tool accessories.
- Company Name: Stryker Instruments
- Publication Date: 2023-07-14
- Product Name: Bone power systems, orthopedic tools and accessories
- Recall Level: Level 3 Recall
- Recall Reason: Product label confusion
- Discovering Company: Stryker (Beijing) Medical Devices Co., Ltd.
- Manufacturing Company: Stryker Instruments
- Summary: On July 14, 2023, Stryker Instruments, through its subsidiary Stryker (Beijing) Medical Devices Co., Ltd., initiated a voluntary Class III recall of specific bone power systems and orthopedic tool accessories. This action was prompted by identified product labeling confusion, which could potentially impact the correct identification and use of the medical devices. The affected products include orthopedic tool accessories (National Medical Device Registration Certificate 20162044946) and bone power systems (National Medical Device Registration Certificate 20162042965). Detailed information regarding the models, specifications, and batches subject to the recall is provided in an accompanying Medical Device Recall Event Report Form. This recall falls under the regulatory oversight of China's National Medical Products Administration (NMPA), which published the notification. A Class III recall indicates a situation where use of, or exposure to, a violative product is not likely to cause adverse health consequences. Stryker's proactive measure underscores its commitment to product safety and regulatory compliance, addressing the labeling discrepancy to ensure proper product management and prevent potential user errors. The company is working to mitigate any risks associated with the labeling issue and ensure the integrity of its medical device offerings in the market.

Company: https://www.globalkeysolutions.net/companies/stryker-instruments/62d0d5c7-3553-49ac-970a-b221e18f7c54/