# China NMPA Product Recall - UroLift System for transurethral implantation of prostate staples

Source: https://www.globalkeysolutions.net/records/china_product_recall/neotract-inc-a-us-based-company/94bb8d3a-e387-4d51-a8c6-98f75aab882c/
Source feed: China

> China NMPA product recall for UroLift System for transurethral implantation of prostate staples by NeoTract, Inc., a US-based company. published August 10, 2022. Recall level: Level 2 Recall. NeoTract, Inc., through its distributor Telefel Medical Devices Trading (Shanghai) Co., Ltd., has in

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: NeoTract, Inc. of the United States has initiated a voluntary recall of its UroLift transurethral implantable prostate staple system.
- Company Name: NeoTract, Inc., a US-based company.
- Publication Date: 2022-08-10
- Product Name: UroLift System for transurethral implantation of prostate staples
- Recall Level: Level 2 Recall
- Recall Reason: There is a possibility that the implant may not be successfully delivered into the body in one go.
- Discovering Company: Telif Medical Devices Trading (Shanghai) Co., Ltd.
- Manufacturing Company: NeoTract, Inc., a US-based company.
- Summary: NeoTract, Inc., through its distributor Telefel Medical Devices Trading (Shanghai) Co., Ltd., has initiated a voluntary Class II recall of its UroLift Transurethral Prostate Staple System (Registration Certificate No.: 20223130205). The recall was publicly announced on August 10, 2022, by the National Medical Products Administration (NMPA). This action was taken due to a specific product model and batch experiencing a critical issue where the implant may not be successfully released into the body in a single attempt during the procedure. The manufacturer, NeoTract, Inc., is responsible for the recall. Further details regarding the affected product models, specifications, and batch numbers are available in the accompanying "Medical Event Report Form" and "Enterprise Recall Report Form" attachments. The NMPA, as the hosting regulatory body, oversees this medical device recall event, ensuring compliance with established medical device regulations and patient safety standards.

Company: https://www.globalkeysolutions.net/companies/neotract-inc-a-us-based-company/271d6ce2-456a-474f-8fc7-932479b4cae7/