# China NMPA Product Recall - Orthopedic surgical navigation system

Source: https://www.globalkeysolutions.net/records/china_product_recall/stryker-leibinger-gmbh-cokg/71fae37a-8987-4b21-973a-58df45c4c9fd/
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 of its Orthopedic Surgical Navigation System. This action was reported by the National Medical Products Administration (NMPA) on October 30, 2017, following a recall event report dated October 17, 2017.

The recall was necessitated by a manufacturing issue involving the system's thoracic pedicle probe. It was discovered that a laser marking machine used for marking the probe's distance operated with an energy value higher than intended. This excessive energy caused material reduction and chipping at the probe head's marking location.

The affected product, registered under National Medical Device Registration Certificate 20163700600, is used for navigation and positioning in various orthopedic surgeries, including spinal, knee, bone tumor, implant, and hip procedures. The recall extends globally, impacting regions such as Australia, Canada, China, Germany, Japan, Singapore, Taiwan, Thailand, the United Kingdom, and the USA. The company's immediate action is to recall affected units to mitigate potential risks and uphold product quality standards under NMPA oversight.

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