# China NMPA Product Recall - Spinal surgical instrument pack

Source: https://www.globalkeysolutions.net/records/china_product_recall/synthes-gmbh/8c1f41da-9753-4608-8fac-bad6cf1e7f74
Source feed: China

> China NMPA product recall for Spinal surgical instrument pack by Synthes GmbH published May 06, 2020. Recall level: Level 3 Recall. The National Medical Products Administration (NMPA) publicly announced a voluntary Class III recall 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Synthes GmbH voluntarily recalls spinal surgery instrument packs
- Company Name: Synthes GmbH
- Publication Date: 2020-05-06
- Product Name: Spinal surgical instrument pack
- Recall Level: Level 3 Recall
- Recall Reason: This issue involves incorrect installation of components from specific product models or batches, resulting in the inability to connect the clamping ring.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Synthes GmbH
- Summary: The National Medical Products Administration (NMPA) publicly announced a voluntary Class III recall pertaining to spinal surgical instrument kits manufactured by Synthes GmbH. This recall was initiated after Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. reported a significant product defect. The core issue involved the incorrect installation of components within specific models and batches of the instrument kits, critically impairing the connection of the clamping ring. Such a malfunction could compromise the integrity and safety of spinal surgical procedures, potentially leading to operational difficulties or adverse patient outcomes. The recall, officially published on May 6, 2020, highlights the manufacturer's proactive commitment to maintaining product quality and ensuring patient safety. Synthes GmbH, recognizing the manufacturing error, voluntarily undertook the recall to address the identified non-conformity. While specific inspection dates were not detailed, the prompt action following the discovery of the defect demonstrates adherence to regulatory responsibilities. Healthcare providers and users are directed to refer to the "Medical Device Recall Event Report Form" for comprehensive information on affected product models, specifications, and batch numbers, enabling them to identify and remove all compromised instruments from use. This measure aligns with the NMPA's stringent regulatory framework designed to oversee medical device safety and ensure manufacturers uphold the highest quality assurance standards, thereby preventing potential risks in clinical settings.

Company: https://www.globalkeysolutions.net/companies/synthes-gmbh/77a06946-ba7a-4bf2-916a-600eabfb0ce7