# China NMPA Product Recall - Total Ankle Surgery Instrument Kit

Source: https://www.globalkeysolutions.net/records/china_product_recall/wright-medical-technology-inc-usa/7bcaa948-99c8-4ac4-8d7e-9c90071f0c1a/
Source feed: China

> China NMPA product recall for Total Ankle Surgery Instrument Kit by Wright Medical Technology, Inc. (USA) published July 04, 2023. Recall level: Level 3 Recall. Wright Medical Technology, Inc., with Stryker (Beijing) Medical Devices Co., Ltd. reporting, has ini

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Wright Medical Technology, Inc. is voluntarily recalling its total ankle surgery instrument kit.
- Company Name: Wright Medical Technology, Inc. (USA)
- Publication Date: 2023-07-04
- Product Name: Total Ankle Surgery Instrument Kit
- Recall Level: Level 3 Recall
- Recall Reason: The bone pin sleeve mounting holes on the orthopedic locators from two different batches are too narrow.
- Discovering Company: Stryker (Beijing) Medical Devices Co., Ltd.
- Manufacturing Company: Wright Medical Technology, Inc. (USA)
- Summary: Wright Medical Technology, Inc., with Stryker (Beijing) Medical Devices Co., Ltd. reporting, has initiated a voluntary recall of its ankle surgery instrument kit (National Medical Device Registration No. 20191444). The National Medical Products Administration (NMPA) has classified this as a Class III recall. The core issue involves a manufacturing defect in two batches of orthopedic locators within the kits, where the mounting holes for the bone pin sleeves were found to be excessively narrow. This defect potentially compromises the intended use and functionality of the surgical instruments, which could impact surgical precision. While specific inspection dates are not provided, this recall was publicly reported on July 4, 2023. The required action by the manufacturer is the voluntary recall of the affected kits. Full details concerning the specific models, specifications, and batch numbers of the impacted products are available in the accompanying "Medical Device Recall Event Report Form."

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