# China NMPA Product Recall - Knee components

Source: https://www.globalkeysolutions.net/records/china_product_recall/biomet-orthopedics/ac68f627-d4e3-455b-a4f0-fe21c7ddf18d
Source feed: China

> China NMPA product recall for Knee components by Biomet Orthopedics published January 24, 2019. Recall level: Level 2 Recall. Zimmer Medical (Shanghai) International Trading Co., Ltd. reported a Class II voluntary recall initi

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Biomet Orthopedics initiates recall of knee components.
- Company Name: Biomet Orthopedics
- Publication Date: 2019-01-24
- Product Name: Knee components
- Recall Level: Level 2 Recall
- Recall Reason: Potential mixing could result in the implant size not matching the size on the label.
- Discovering Company: Zimmer Medical (Shanghai) International Trading Co., Ltd.
- Manufacturing Company: Biomet Orthopedics
- Summary: Zimmer Medical (Shanghai) International Trading Co., Ltd. reported a Class II voluntary recall initiated by its manufacturer, Biomet Orthopedics, concerning specific knee joint components (National Medical Device Registration Certificate 20173460467). This recall, overseen by the National Medical Products Administration (NMPA), addresses a critical issue involving potential product mixing that could result in a mismatch between the implant size and its corresponding label for Vanguard Knee Series A Three-Column Standard Patellar Components. Such a discrepancy could compromise patient safety and surgical outcomes. Importantly, while the recall was reported in China, the affected product batches were explicitly confirmed as not having been sold within the Chinese market. The recall primarily targeted international regions, including the USA, Japan, South Korea, and New Zealand. Consequently, no domestic corrective actions or specific handling methods were required or implemented by Zimmer Medical (Shanghai) International Trading Co., Ltd. in China, as the non-conforming products were not distributed locally. The recall notification was formally submitted on December 27, 2018, ensuring regulatory transparency.

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