# China NMPA Product Recall - Bone Powered Surgical System

Source: https://www.globalkeysolutions.net/records/china_product_recall/stryker-instruments/ce587f8f-5a03-4d69-a0f5-77dd3f8056ba/
Source feed: China

> China NMPA product recall for Bone Powered Surgical System by Stryker Instruments published October 08, 2024. Recall level: Level 3 Recall. The National Medical Products Administration (NMPA) announced a voluntary Class III recall initiated

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Stryker Instruments initiates proactive recall of bone power systems
- Company Name: Stryker Instruments
- Publication Date: 2024-10-08
- Product Name: Bone Powered Surgical System
- Recall Level: Level 3 Recall
- Recall Reason: Endotoxin levels exceeded the limit
- Discovering Company: Stryker (Beijing) Medical Devices Co., Ltd.
- Manufacturing Company: Stryker Instruments
- Summary: The National Medical Products Administration (NMPA) announced a voluntary Class III recall initiated by Stryker Instruments, reported by Stryker (Beijing) Medical Devices Co., Ltd. on October 8, 2024 (Index No. JGXX-2024-10166). This action concerns the Bone Powered Surgical System (Recall No. 20162042965). The main issue identified was endotoxin levels exceeding established limits within the product. The regulatory framework for this recall is provided by the NMPA in China. The required action is a voluntary recall by the manufacturer. It is specified that the products involved in this particular recall were not imported into China. The document did not provide specific inspection dates, but the voluntary recall demonstrates the company's responsiveness to quality issues under NMPA's oversight. Further details regarding specific models, specifications, and batches are available in the Medical Device Recall Event Report Form.

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