# China NMPA Product Recall - Spinal internal fixation system components (Xia implants), anterior fixation system

Source: https://www.globalkeysolutions.net/records/china_product_recall/stryker-spine-inc/8b450440-c2e8-4507-ab32-1bf5c8228520/
Source feed: China

> China NMPA product recall for Spinal internal fixation system components (Xia implants), anterior fixation system by Stryker Spine Inc. published November 25, 2021. Recall level: Level 3 Recall. Stryker Spine Corporation has initiated a voluntary Class III recall of specific spinal internal fix

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Stryker Spine Inc. is voluntarily recalling products including spinal internal fixation system components such as Xia implants.
- Company Name: Stryker Spine Inc.
- Publication Date: 2021-11-25
- Product Name: Spinal internal fixation system components (Xia implants), anterior fixation system
- Recall Level: Level 3 Recall
- Recall Reason: Products sold to South Korea, Taiwan, and Mexico do not have paper instruction manuals; they only have electronic instruction labels.
- Discovering Company: Stryker (Beijing) Medical Devices Co., Ltd.
- Manufacturing Company: Stryker Spine Inc.
- Summary: Stryker Spine Corporation has initiated a voluntary Class III recall of specific spinal internal fixation system components, including Xia implants and anterior fixation systems. This action, reported by Stryker (Beijing) Medical Devices Co., Ltd., is overseen by the National Medical Products Administration (NMPA). The primary issue prompting this recall involves certain product models and batches distributed to South Korea, Taiwan, and Mexico. These affected medical devices were found to lack essential paper instructions for use, relying solely on electronic versions. While the core functionality of the implants is not cited as compromised, the absence of physical instructions represents a significant deviation from standard product presentation and regulatory requirements for medical devices. This discrepancy in documentation necessitated the recall to ensure full compliance with regulatory expectations and to provide comprehensive guidance to medical professionals. The voluntary recall underscores Stryker Spine Corporation's commitment to product integrity and adherence to international distribution standards. Detailed information regarding the precise models, specifications, and batch numbers affected by this recall is provided in the "Medical Device Recall Event Report Form" attached to the official NMPA notice. This proactive measure aims to ensure all users receive complete product information.

Company: https://www.globalkeysolutions.net/companies/stryker-spine-inc/956029de-236c-4bfa-9fed-349cddcd8864/