# China NMPA Product Recall - K Prostheses Total Knee Prosthesis System

Source: https://www.globalkeysolutions.net/records/china_product_recall/zimmer-dental-inc-usa/bec491f3-943c-46b9-bb9f-f78dc7006c90/
Source feed: China

> China NMPA product recall for K Prostheses Total Knee Prosthesis System by Zimmer Dental Inc. (USA) published April 17, 2024. Recall level: Level 2 Recall. Zimmer Inc., a prominent medical device manufacturer, has initiated a voluntary Class II recall of i

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Zimmer Inc. of the United States has initiated a voluntary recall of its total knee prosthesis system.
- Company Name: Zimmer Dental Inc. (USA)
- Publication Date: 2024-04-17
- Product Name: K Prostheses Total Knee Prosthesis System
- Recall Level: Level 2 Recall
- Recall Reason: The tensile properties of the sample exceeded the specified limits.
- Discovering Company: Zimmer Medical (Shanghai) International Trading Co., Ltd.
- Manufacturing Company: Zimmer Dental Inc. (USA)
- Summary: Zimmer Inc., a prominent medical device manufacturer, has initiated a voluntary Class II recall of its Total Knee Prosthesis System (National Medical Device Registration Certificate No. 20143135628). This action, publicly announced by the National Medical Products Administration (NMPA) on April 17, 2024, stems from critical quality control issues. Specifically, samples of the prostheses were identified to possess tensile properties that exceeded specified limits, indicating a potential compromise in the product's structural integrity and long-term performance. Zimmer (Shanghai) Medical International Trading Co., Ltd. reported this recall, which signifies that the product's use may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. The company's proactive measure underscores its commitment to patient safety and product reliability, aligning with the regulatory oversight of the NMPA. Detailed information regarding affected product models, specifications, and batch numbers is available in the official "Medical Device Recall Event Report Form."

Company: https://www.globalkeysolutions.net/companies/zimmer-dental-inc-usa/d8307bca-719e-4f8b-b35a-88a32308842c/