# China NMPA Product Recall - Swanson Small Joint Orthopedic Implants

Source: https://www.globalkeysolutions.net/records/china_product_recall/wright-medical-technology-inc-usa/a900168e-7dd1-4799-9b00-4fbdbad2e0da/
Source feed: China

> China NMPA product recall for Swanson Small Joint Orthopedic Implants by Wright Medical Technology, Inc. (USA) published September 07, 2022. Recall level: Level 2 Recall. Wright Medical Technology, Inc., a U.S.-based company, initiated a voluntary Class II recall of its 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Wright Medical Technology, Inc. of the United States has initiated a voluntary recall of its Swanson Small Joint Orthopedic Implants.
- Company Name: Wright Medical Technology, Inc. (USA)
- Publication Date: 2022-09-07
- Product Name: Swanson Small Joint Orthopedic Implants
- Recall Level: Level 2 Recall
- Recall Reason: The problem is that an incorrect implant size label was affixed to the outer packaging box.
- Discovering Company: Ruiyi Medical Devices (Shanghai) Co., Ltd.
- Manufacturing Company: Wright Medical Technology, Inc. (USA)
- Summary: Wright Medical Technology, Inc., a U.S.-based company, initiated a voluntary Class II recall of its Swanson Small Joint Orthopedic Implants. This action was officially announced by the National Medical Products Administration (NMPA) on September 7, 2022, following a report from Wright Medical Devices (Shanghai) Co., Ltd. The core issue identified was an incorrect implant size label affixed to the outer packaging of specific models and batches of the affected products. This labeling error represents a potential risk, as it could lead to the selection and use of an improperly sized implant for patients. The regulatory framework for this action falls under the NMPA's medical device recall system, with a Class II designation, indicating a situation where product use may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. The required action by the company is the voluntary recall of the implicated products, specifically those under Registration Certificate No.: 20143136168. Further details on precise models, specifications, and batch numbers are provided in an attached Medical Device Recall Event Report Form, accompanying the NMPA's public notification, to ensure comprehensive remediation of the labeling discrepancy.

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