# China NMPA Product Recall - DARCO Plating System for small bone fracture fixation

Source: https://www.globalkeysolutions.net/records/china_product_recall/wright-medical-technology-inc-usa/a58da17d-7935-4fc7-9000-7235dc7fee55/
Source feed: China

> China NMPA product recall for DARCO Plating System for small bone fracture fixation by Wright Medical Technology, Inc. (USA) published April 12, 2022. Recall level: Level 3 Recall. On April 12, 2022, Wright Medical Technology, Inc. (USA), in collaboration with its subsidiary Wrigh

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Wright Medical Technology, Inc., Inc. is voluntarily recalling its DARCO Plating System for small bone fracture fixation.
- Company Name: Wright Medical Technology, Inc. (USA)
- Publication Date: 2022-04-12
- Product Name: DARCO Plating System for small bone fracture fixation
- Recall Level: Level 3 Recall
- Recall Reason: There is an issue with incorrect production and expiration dates.
- Discovering Company: Ruiyi Medical Devices (Shanghai) Co., Ltd.
- Manufacturing Company: Wright Medical Technology, Inc. (USA)
- Summary: On April 12, 2022, Wright Medical Technology, Inc. (USA), in collaboration with its subsidiary Wright Medical Devices (Shanghai) Co., Ltd., announced a voluntary recall of its DARCO Plating System, specifically designed for small bone fracture fixation. The National Medical Products Administration (NMPA) recorded this as a Class III recall. The primary issue identified was critical errors in the production and expiration dates for specific models and batches of the affected devices. This action addresses potential risks associated with inaccurate dating information, which could compromise product efficacy or patient safety if devices are used outside their intended lifespan or if their manufacturing details are incorrect. While specific models and batch numbers are detailed in an attached report, the overarching concern relates to fundamental data integrity in product lifecycle management. This recall demonstrates Wright Medical Technology's commitment to regulatory compliance and patient welfare, ensuring the removal of all impacted products to prevent any adverse events stemming from these dating discrepancies.

Company: https://www.globalkeysolutions.net/companies/wright-medical-technology-inc-usa/c7becb78-11be-4685-97b6-3d9aa21d105f/