# China NMPA Product Recall - Hip Joint Prostheses - Ceramic Femoral Head and Liner

Source: https://www.globalkeysolutions.net/records/china_product_recall/zimmer-gmbh/8046ede1-f62a-4fd3-8bda-132e7d820c2d/
Source feed: China

> China NMPA product recall for Hip Joint Prostheses - Ceramic Femoral Head and Liner by Zimmer GmbH published November 17, 2023. Recall level: Level 3 Recall. Zimmer GmbH, a Swiss medical device manufacturer, has initiated a voluntary Class III recall of its 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Zimmer GmbH of Switzerland is issuing a voluntary recall for its hip prostheses – ceramic femoral heads and liners.
- Company Name: Zimmer GmbH
- Publication Date: 2023-11-17
- Product Name: Hip Joint Prostheses - Ceramic Femoral Head and Liner
- Recall Level: Level 3 Recall
- Recall Reason: The interfaces on the packaging of certain models and batches of products may be incorrect.
- Discovering Company: Zimmer Medical (Shanghai) International Trading Co., Ltd.
- Manufacturing Company: Zimmer GmbH
- Summary: Zimmer GmbH, a Swiss medical device manufacturer, has initiated a voluntary Class III recall of its hip joint prostheses, specifically the ceramic femoral head and liner. This recall, reported by Zimmer (Shanghai) Medical International Trading Co., Ltd. on November 17, 2023, falls under the regulatory oversight of China's National Medical Products Administration (NMPA). The core issue prompting this action is a potential "incorrect interface in the packaging" affecting specific models and batches of these critical implantable devices. Such a packaging anomaly could potentially compromise the sterility or integrity of the product prior to use, posing a risk to patient safety. The recalled devices are registered under National Medical Device Registration Certificate No. 20143135650. Comprehensive details, including the exact models, specifications, and batch numbers involved, are outlined in the accompanying "Medical Device Recall Event Report Form." This proactive recall by Zimmer GmbH underscores their commitment to product quality and patient safety, addressing a potential risk before it leads to adverse patient outcomes, and demonstrates adherence to NMPA's medical device regulations.

Company: https://www.globalkeysolutions.net/companies/zimmer-gmbh/302d2715-92f8-4c43-b414-187e93b9b7ca/