# China NMPA Product Recall - Inverted shoulder joint system

Source: https://www.globalkeysolutions.net/records/china_product_recall/biomet-orthopedics/322e1a25-1129-490b-b866-e3ac2a8aebfd/
Source feed: China

> China NMPA product recall for Inverted shoulder joint system by Biomet Orthopedics published March 03, 2020. Recall level: Level 2 Recall. On March 3, 2020, the National Medical Products Administration (NMPA) published details regarding a 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Biomet Orthopedics voluntarily recalls its inverted shoulder joint system.
- Company Name: Biomet Orthopedics
- Publication Date: 2020-03-03
- Product Name: Inverted shoulder joint system
- Recall Level: Level 2 Recall
- Recall Reason: Packaging errors exist in certain batches.
- Discovering Company: Zimmer Medical (Shanghai) International Trading Co., Ltd.
- Manufacturing Company: Biomet Orthopedics
- Summary: On March 3, 2020, the National Medical Products Administration (NMPA) published details regarding a Class II voluntary recall of the Inverted Shoulder Joint System, initiated by its manufacturer, Biomet Orthopedics. This significant recall, reported by Zimmer Medical (Shanghai) International Trading Co., Ltd., was not a result of a regulatory inspection but a proactive measure taken by the company. The core issue prompting this action was identified as a packaging error affecting a specific batch of the medical device, which is registered under the NMPA with registration number 20163461824. Under the regulatory framework of the NMPA, which governs medical device safety and quality in China, a Class II recall addresses situations where the use of a violative product may lead to temporary or medically reversible adverse health consequences, or where the likelihood of serious adverse health consequences is remote. Biomet Orthopedics' required action involves systematically removing the affected products from the market to prevent any potential risks to patients. Comprehensive information, including the specific models, specifications, and batch numbers of the impacted devices, is available in the "Medical Device Recall Event Report Form." This demonstrates the company's commitment to patient safety and adherence to product quality standards.

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