# China NMPA Product Recall - Disposable bone cement molds for temporary femoral prosthesis molding; bone cement molding molds for knee joints.

Source: https://www.keypedia.com/records/china_product_recall/zimmer-medical-shanghai-international-trading-co-ltd/c0c67f60-e619-4608-bd6d-a4cf6ac73ef6
Source feed: China

> China NMPA product recall for Disposable bone cement molds for temporary femoral prosthesis molding; bone cement molding molds for knee joints. by Zimmer Medical (Shanghai) International Trading Co., Ltd. published March 03, 2020. Recall level: Level 2 Recall. Zimmer Biomet (Shanghai) Medical International Trading Co., Ltd. initiated a voluntary Class II reca

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Zimmer Medical (Shanghai) International Trading Co., Ltd. is voluntarily recalling disposable bone cement molds for temporary femoral prosthesis molding and bone cement molding molds for knee joints.
- Company Name: Zimmer Medical (Shanghai) International Trading Co., Ltd.
- Publication Date: 2020-03-03
- Product Name: Disposable bone cement molds for temporary femoral prosthesis molding; bone cement molding molds for knee joints.
- Recall Level: Level 2 Recall
- Recall Reason: The product in question may have potential deficiencies in its cleaning process or insufficient monitoring of cleaning parameters.
- Discovering Company: Zimmer Medical (Shanghai) International Trading Co., Ltd.
- Manufacturing Company: Zimmer Medical (Shanghai) International Trading Co., Ltd.
- Summary: Zimmer Biomet (Shanghai) Medical International Trading Co., Ltd. initiated a voluntary Class II recall of specific disposable bone cement molds, as reported by the National Medical Products Administration (NMPA) on March 3, 2020. This action, also highlighted by the Shanghai Municipal Drug Administration, impacts all batches of disposable bone cement molds for temporary femoral prosthesis molding (Registration Certificate No.: 20163461466) and bone cement molding molds for knee joints (Registration Certificate No.: 20162101535). The recall stems from issues discovered during a complaint investigation, revealing a potential deficiency in the cleaning process or insufficient monitoring of cleaning parameters for these medical devices. The company is actively addressing the concern by removing the affected products from the market to ensure patient safety and compliance with medical device regulations under the NMPA framework.

Company: https://www.keypedia.com/companies/zimmer-medical-shanghai-international-trading-co-ltd/22d50256-8f36-4c1a-ba7d-ae035c933119