# China NMPA Product Recall - Disposable bone cement mold for temporary femoral prosthesis molding

Source: https://www.globalkeysolutions.net/records/china_product_recall/biomet-orthopedics/f6f3f751-9369-4ca9-8ec0-78a23971652a/
Source feed: China

> China NMPA product recall for Disposable bone cement mold for temporary femoral prosthesis molding by Biomet Orthopedics published October 31, 2018. Recall level: Level 2. The National Medical Products Administration (NMPA) announced a Class II voluntary recall initiated 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Biomet Orthopedics is voluntarily recalling disposable bone cement molds used for temporary femoral prosthesis molding.
- Company Name: Biomet Orthopedics
- Publication Date: 2018-10-31
- Product Name: Disposable bone cement mold for temporary femoral prosthesis molding
- Recall Level: Level 2
- Recall Reason: There is a potential risk of product batch mixing.
- Discovering Company: Zimmer Medical (Shanghai) International Trading Co., Ltd.
- Manufacturing Company: Biomet Orthopedics
- Summary: The National Medical Products Administration (NMPA) announced a Class II voluntary recall initiated by Biomet Orthopedics, reported by its agent Zimmer Medical (Shanghai) International Trading Co., Ltd. The recall, detailed in a report dated September 27, 2018, concerns disposable bone cement molds for temporary femoral prosthesis molding (NMPA Registration No.: 20163461466). The primary reason for the recall is a potential batch mixing risk identified by the manufacturer, affecting specific batches including 705550, 705570, and 705580 for product models 431207 and 431209. These molds are intended for preparing temporary femoral prostheses for revision replacement due to hip prosthesis infection. While the recall impacts regions such as Canada, Australia, the EU, and the USA, it is important to note that the specific problematic batches were not sold or distributed within China. Therefore, no direct actions are required for products currently in the Chinese market, as this serves as a proactive measure by Zimmer Biomet to address the identified quality control issue globally.

Company: https://www.globalkeysolutions.net/companies/biomet-orthopedics/9bcf230e-90e5-4f4e-8673-6456e0ed8783/