# China NMPA Product Recall - Total knee replacement system

Source: https://www.globalkeysolutions.net/records/china_product_recall/depuy-ireland/da4bbbde-7684-458e-8060-fd26ef3370e0/
Source feed: China

> China NMPA product recall for Total knee replacement system by DePuy (Ireland) published September 30, 2016. Recall level: Level III. Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. initiated a voluntary Class III recall for sp

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. voluntarily recalls total knee replacement systems.
- Company Name: DePuy (Ireland)
- Publication Date: 2016-09-30
- Product Name: Total knee replacement system
- Recall Level: Level III
- Recall Reason: The affected products of specific models and batches were mistakenly given Chinese instruction manuals for other products under the same registration certificate. However, the surgical technique guidelines instructing doctors on how to use the products were correct. The added Chinese instruction manuals did not increase the risk to patients, and no related complaints or adverse events were reported.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: DePuy (Ireland)
- Summary: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. initiated a voluntary Class III recall for specific batches of its Total Knee Replacement System, manufactured by DePuy (Ireland). The recall was formally reported on July 7, 2016, and publicly announced by the National Medical Products Administration (NMPA) on September 30, 2016.The primary issue identified was an incorrect labeling error: certain product models were packaged with Chinese instructions for use intended for other products under the same registration certificate. Importantly, the surgical technique guidelines provided to medical professionals for using the specific recalled knee replacement system were correct. Johnson & Johnson affirmed that this labeling discrepancy did not increase patient risk, and no related complaints or adverse event reports had been received concerning the affected units.Operating under the NMPA's regulatory framework for medical devices, the company’s required immediate action involved notifying all affected customers. These customers were instructed to promptly identify and quarantine any inventory of the recalled Total Knee Replacement Systems. This voluntary recall demonstrates the company's commitment to product integrity and adherence to Chinese medical device regulations, even for issues deemed low risk.

Company: https://www.globalkeysolutions.net/companies/depuy-ireland/00dbdd74-5cb2-4bbd-8581-db4fbb3df9aa/