# China NMPA Product Recall - Orthopedic surgical navigation system

Source: https://www.globalkeysolutions.net/records/china_product_recall/stryker-leibinger-gmbh-cokg/9f56885e-925f-4cd7-8c87-28b7c3578861/
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

---

## 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 of its Orthopedic Surgical Navigation System (National Medical Device Registration Certificate 20163700600). This action was reported on October 17, 2017, and published by the National Medical Products Administration (NMPA) on October 30, 2017. The core issue stemmed from a manufacturing flaw where the laser marking machine, used for the thoracic pedicle probe, was set to an unexpectedly high energy value. This led to material reduction and chipping at the probe head's marking location, potentially affecting the device's integrity. Consequently, Stryker recalled specific product models, including 6002-350-000, with serial numbers 10915 and 10916. The recall spanned multiple countries and regions, such as Australia, Canada, China, Germany, Japan, Singapore, Taiwan, Thailand, the United Kingdom, and the USA. Under the NMPA's regulatory framework, Stryker undertook this proactive measure to address the material defect and ensure the safety and reliability of its medical devices globally, despite no sales of the affected batches being reported in China.

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