# China NMPA Product Recall - Orthopedic surgical navigation system

Source: https://www.globalkeysolutions.net/records/china_product_recall/mako-surgical-corp-a-us-based-orthopedic-company/93b3b6d9-8cb1-41a4-bcb9-7c5015fc3ae8/
Source feed: China

> China NMPA product recall for Orthopedic surgical navigation system by MAKO Surgical Corp., a US-based orthopedic company. published August 18, 2020. Recall level: Level 2 Recall. The National Medical Products Administration (NMPA) announced a Class II voluntary recall initiated 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: MAKO Surgical Corp., a US-based orthopedic surgery company, is voluntarily recalling its orthopedic surgical navigation system.
- Company Name: MAKO Surgical Corp., a US-based orthopedic company.
- Publication Date: 2020-08-18
- Product Name: Orthopedic surgical navigation system
- Recall Level: Level 2 Recall
- Recall Reason: There are program output errors in certain models and batches of products.
- Discovering Company: Stryker (Beijing) Medical Devices Co., Ltd.
- Manufacturing Company: MAKO Surgical Corp., a US-based orthopedic company.
- Summary: The National Medical Products Administration (NMPA) announced a Class II voluntary recall initiated by MAKO Surgical Corp. for its orthopedic surgical navigation system. Reported by Stryker (Beijing) Medical Devices Co., Ltd. on August 18, 2020, the recall addresses a critical program output error identified in specific models and batches of the device. This issue necessitates the system's removal from the market to prevent potential adverse health consequences, although the probability of serious harm is considered remote, typical for a Class II recall. The regulatory framework for this action falls under the NMPA's authority in China, which oversees medical device safety and compliance. The required actions involve the manufacturer, MAKO Surgical Corp., undertaking this voluntary recall to correct the identified deficiency. Further detailed information regarding the affected product models, specifications, and batches is available in the 

Company: https://www.globalkeysolutions.net/companies/mako-surgical-corp-a-us-based-orthopedic-company/c18d4733-8d7b-42d4-8223-20f08f9c4802/