# China NMPA Product Recall - Inverted shoulder joint system

Source: https://www.globalkeysolutions.net/records/china_product_recall/biomet-orthopedics/2ab539bf-4de7-4b49-98d2-fd0723c32b7f/
Source feed: China

> China NMPA product recall for Inverted shoulder joint system by Biomet Orthopedics published September 18, 2020. Recall level: Level 2 Recall. Biomet Orthopedics, through Zimmer Medical (Shanghai) International Trading Co., Ltd., initiated a v

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Biomet Orthopedics initiates recall of inverted shoulder joint system
- Company Name: Biomet Orthopedics
- Publication Date: 2020-09-18
- Product Name: Inverted shoulder joint system
- Recall Level: Level 2 Recall
- Recall Reason: There are assembly errors in certain models and batches of products; the number of shoulder straps and adapters inside the packaging is incorrect.
- Discovering Company: Zimmer Medical (Shanghai) International Trading Co., Ltd.
- Manufacturing Company: Biomet Orthopedics
- Summary: Biomet Orthopedics, through Zimmer Medical (Shanghai) International Trading Co., Ltd., initiated a voluntary Class II recall of its inverted shoulder joint system (Registration Certificate No.: 20163461824) on September 17, 2020. The recall was prompted by identified manufacturing issues, specifically assembly errors and incorrect quantities of shoulder caps and adapters within certain product models and batches. This action falls under the regulatory oversight of the National Medical Products Administration (NMPA) in China, which published the notice on September 18, 2020. The required action is the complete recall of the affected medical devices to address these critical defects, with detailed information available in the "Medical Device Recall Event Report Form" attachment. This proactive measure ensures patient safety and product integrity by removing non-conforming products from distribution.

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