# China NMPA Product Recall - Ogival Interbody interbody fusion device

Source: https://www.globalkeysolutions.net/records/china_product_recall/stryker-spine-corporation/0737c60d-547f-4c52-a2f0-96308f8e6e38/
Source feed: China

> China NMPA product recall for Ogival Interbody interbody fusion device by Stryker Spine Corporation published June 01, 2023. Recall level: Level 3 Recall. Stryker Spine Corporation, through its Beijing subsidiary Stryker (Beijing) Medical Devices Co., Ltd

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Stryker Spine Inc. is voluntarily recalling its interbody fusion devices.
- Company Name: Stryker Spine Corporation
- Publication Date: 2023-06-01
- Product Name: Ogival Interbody interbody fusion device
- Recall Level: Level 3 Recall
- Recall Reason: Incorrect height marking of interbody fusion device
- Discovering Company: Stryker (Beijing) Medical Devices Co., Ltd.
- Manufacturing Company: Stryker Spine Corporation
- Summary: Stryker Spine Corporation, through its Beijing subsidiary Stryker (Beijing) Medical Devices Co., Ltd., has initiated a voluntary Class III recall of its Ogival Interbody Fusion Device (National Medical Device Registration Certificate 20163131310). This action, publicized by the National Medical Products Administration (NMPA) on June 1, 2023, stems from an identified manufacturing issue: incorrect height markings on the interbody fusion devices. The recall is categorized as Class III, indicating that while the defect is not expected to cause serious adverse health consequences, it represents a deviation from product specifications that warrants corrective action. The NMPA's involvement underscores its role in overseeing medical device safety and ensuring manufacturers adhere to established quality and regulatory standards within China. Stryker's proactive recall demonstrates compliance with the regulatory framework governing medical devices, ensuring patient safety and product integrity. The company is required to provide detailed information on affected models, specifications, and batch numbers in an official recall report form, accessible through the NMPA's official channels.

Company: https://www.globalkeysolutions.net/companies/stryker-spine-corporation/4bbce39d-c234-49d0-a52a-eb4d073fad0c/