# China NMPA Product Recall - Inverted shoulder joint system

Source: https://www.globalkeysolutions.net/records/china_product_recall/zimmer-medical-shanghai-international-trading-co-ltd/f7829402-6623-453a-bc00-d9c75ecda24f/
Source feed: China

> China NMPA product recall for Inverted shoulder joint system by Zimmer Medical (Shanghai) International Trading Co., Ltd. published December 16, 2019. Recall level: Level 2 Recall. On December 16, 2019, Zimmer Biomet (Shanghai) Medical International Trading Co., Ltd. initiated a v

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Zimmer Medical (Shanghai) International Trading Co., Ltd. is voluntarily recalling its inverted shoulder joint system.
- Company Name: Zimmer Medical (Shanghai) International Trading Co., Ltd.
- Publication Date: 2019-12-16
- Product Name: Inverted shoulder joint system
- Recall Level: Level 2 Recall
- Recall Reason: The supplier's final cleaning process may result in elevated levels of bacterial endotoxins and debris residue on the product, leading to inconsistent quality standards.
- Discovering Company: Zimmer Medical (Shanghai) International Trading Co., Ltd.
- Manufacturing Company: Zimmer Medical (Shanghai) International Trading Co., Ltd.
- Summary: On December 16, 2019, Zimmer Biomet (Shanghai) Medical International Trading Co., Ltd. initiated a voluntary Class II recall of its inverted shoulder joint system, as reported by the National Medical Products Administration (NMPA). This decision stemmed from a Food and Drug Administration (FDA) warning letter issued earlier in 2019 to a supplier responsible for the final cleaning of specific Zimmer Biomet products.The company's subsequent evaluation focused on products manufactured prior to an upgraded cleaning process implemented in March 2018. While clinical performance data from over 200,000 global products indicated expected performance, the evaluation revealed that the supplier's quality standards during that earlier period were inconsistent with Zimmer Biomet's current requirements. Consequently, the previous cleaning process may have resulted in elevated bacterial endotoxin levels and residual debris on the devices. Although product sterility was maintained and the risk of infection was not increased, these elevated levels could potentially cause localized tissue reactions.Out of an abundance of caution, Zimmer Biomet decided to recall the affected product batches rather than attempting reprocessing. Products manufactured after the March 2018 cleaning process upgrade and those outside the identified batches are not impacted by this recall. This voluntary measure ensures patient safety and adherence to rigorous product quality standards.

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