# China NMPA Product Recall - Orthopedic surgical navigation system

Source: https://www.globalkeysolutions.net/records/china_product_recall/stryker-leibinger-gmbh-cokg/523de65b-264d-4a74-ab01-ad0d6a76f0b0/
Source feed: China

> China NMPA product recall for Orthopedic surgical navigation system by Stryker Leibinger GmbH & Co.KG published October 30, 2017. Recall level: Level 2 Recall. Stryker Leibinger GmbH & Co.KG, through its agent Stryker (Beijing) Medical Devices Co., Ltd., initi

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Stryker Leibinger GmbH & Co.KG is voluntarily recalling its orthopedic surgical navigation system.
- Company Name: Stryker Leibinger GmbH & Co.KG
- Publication Date: 2017-10-30
- Product Name: Orthopedic surgical navigation system
- Recall Level: Level 2 Recall
- Recall Reason: The distance marked by the thoracic pedicle probe was marked using a laser marking machine. Because the energy value set by the laser marking machine was higher than expected, this change caused the material at the marking point of the thoracic pedicle probe head to be chipped off.
- Discovering Company: Stryker (Beijing) Medical Devices Co., Ltd.
- Manufacturing Company: Stryker Leibinger GmbH & Co.KG
- Summary: Stryker Leibinger GmbH & Co.KG, through its agent Stryker (Beijing) Medical Devices Co., Ltd., initiated a voluntary Level 2 recall for its Orthopedic Surgical Navigation System (NMPA Registration Certificate 20163700600). This action was reported on October 17, 2017, and publicly announced by the National Medical Products Administration (NMPA) on October 30, 2017. The recall stems from a manufacturing issue where the laser marking machine, used for thoracic pedicle probes, had an energy setting exceeding specifications. This resulted in unintended material reduction and chipping at the probe head's marking location, potentially compromising the device's integrity. The regulatory oversight for this recall falls under the NMPA's framework for medical device safety in China. As a required corrective action, Stryker is recalling affected products, specifically models such as 6002-350-000, from the Chinese market and other international regions including Australia, Canada, Germany, Japan, Singapore, Taiwan, Thailand, the UK, and the USA, to mitigate potential risks and ensure product safety.

Company: https://www.globalkeysolutions.net/companies/stryker-leibinger-gmbh-cokg/07673dda-6416-43b9-b3f8-8a0efb142b19/