# China NMPA Product Recall - INBONE Total Ankle System

Source: https://www.globalkeysolutions.net/records/china_product_recall/wright-medical-technology-inc-usa/a2d3adf4-2428-42a3-8dda-a800f960420b/
Source feed: China

> China NMPA product recall for INBONE Total Ankle System by Wright Medical Technology, Inc. (USA) published December 30, 2021. Recall level: Level 3 Recall. The National Medical Products Administration (NMPA) announced on December 30, 2021, a voluntary Clas

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Wright Medical Technology, Inc., a US-based company, is voluntarily recalling its INBONE Total Ankle System.
- Company Name: Wright Medical Technology, Inc. (USA)
- Publication Date: 2021-12-30
- Product Name: INBONE Total Ankle System
- Recall Level: Level 3 Recall
- Recall Reason: There is an issue with incorrect product contents inside the packaging.
- Discovering Company: Ruiyi Medical Devices (Shanghai) Co., Ltd.
- Manufacturing Company: Wright Medical Technology, Inc. (USA)
- Summary: The National Medical Products Administration (NMPA) announced on December 30, 2021, a voluntary Class III recall initiated by Wright Medical Technology, Inc. (USA) concerning its INBONE Total Ankle System. This medical device, registered under certificate No.: 20153132065, is subject to recall due to an identified issue with incorrect product packaging. Specifically, certain models and batches of the INBONE Total Ankle System were found to have packaging discrepancies, a situation that could potentially lead to product mix-ups, compromised sterility, or other usage errors. Wright Medical Technology, Inc. voluntarily undertook this corrective action, recognizing the importance of maintaining product integrity and patient safety. The NMPA classified this as a Class III recall, which typically signifies that the use of or exposure to the affected product is not likely to cause adverse health consequences, but corrective measures are still necessary to address the identified non-conformity. The details concerning the specific affected models, specifications, and batch numbers have been compiled and made available in an attached Medical Device Recall Report Form. This regulatory oversight by the NMPA ensures that medical device manufacturers adhere to stringent quality and safety standards, protecting public health through prompt identification and resolution of product-related issues.

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