# China NMPA Product Recall - Shoulder joint system tools

Source: https://www.globalkeysolutions.net/records/china_product_recall/zimmer-gmbh/267bd21a-4b11-4c90-8a11-ab98f9c681b7/
Source feed: China

> China NMPA product recall for Shoulder joint system tools by Zimmer GmbH published March 27, 2015. Recall level: Level 2 Recall. ZIMMER (Shanghai) Medical International Trading Co., Ltd. initiated a voluntary Class II recall for 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Zimmer Medical (Shanghai) International Trading Co., Ltd. is voluntarily recalling shoulder joint system accessory kits.
- Company Name: Zimmer GmbH
- Publication Date: 2015-03-27
- Product Name: Shoulder joint system tools
- Recall Level: Level 2 Recall
- Recall Reason: The AS humeral reamer handle may be difficult to apply (high resistance); and may be difficult to remove after application (getting stuck between the two components).
- Discovering Company: Zimmer Medical (Shanghai) International Trading Co., Ltd.
- Manufacturing Company: Zimmer GmbH
- Summary: ZIMMER (Shanghai) Medical International Trading Co., Ltd. initiated a voluntary Class II recall for its Shoulder Joint System Accessory Kit, specifically impacting the AS Humeral Rasp Handle (Model/Specification 01.04233.000). The manufacturer, Zimmer GmbH, was involved in this action reported on March 7, 2015, and published by the National Medical Products Administration (NMPA) on March 27, 2015. The primary issue identified was that the AS humeral reamer handle exhibited high resistance during attachment and, once attached, proved difficult to remove, often getting stuck between components. This defect posed a potential risk during surgical procedures involving partial or total shoulder replacement. The recall affected products with batch numbers 13838644 and 13878179, distributed within China. Under the regulatory oversight of the CFDA (now NMPA), ZIMMER (Shanghai) Medical International Trading Co., Ltd. promptly undertook corrective actions. All affected product units were successfully returned from customers to the manufacturer, Zimmer GmbH. This proactive measure ensures the removal of potentially problematic devices from the market, upholding patient safety standards in medical device use.

Company: https://www.globalkeysolutions.net/companies/zimmer-gmbh/302d2715-92f8-4c43-b414-187e93b9b7ca/