# China NMPA Product Recall - Neck immobilizer

Source: https://www.globalkeysolutions.net/records/china_product_recall/ossur-hf/f6796cb4-1f08-4ff2-a616-8e6dcec2d16c/
Source feed: China

> China NMPA product recall for Neck immobilizer by Ossur hf published November 18, 2021. Recall level: Level 3 Recall. On November 18, 2021, Ossur Prosthetics & Orthotics (Shanghai) Co., Ltd. announced a voluntary Class

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Osso Prosthetics & Orthotics Rehabilitation Equipment (Shanghai) Co., Ltd. is voluntarily recalling its cervical fixation device.
- Company Name: Ossur hf
- Publication Date: 2021-11-18
- Product Name: Neck immobilizer
- Recall Level: Level 3 Recall
- Recall Reason: The issue arises because the manufacturer, Ossur hf, has decided to update the safety and warning information in the instructions for use of its Miami J Select product in order to comply with Australian regulatory requirements. While an assessment has determined that this update will not cause harm to patients, considering the potential risks and to make it easier for patients to choose and use the product, the manufacturer has decided to update the instructions and send a safety bulletin to users.
- Discovering Company: Osso Prosthetics & Orthotics Rehabilitation Equipment (Shanghai) Co., Ltd.
- Manufacturing Company: Ossur hf
- Summary: On November 18, 2021, Ossur Prosthetics & Orthotics (Shanghai) Co., Ltd. announced a voluntary Class III recall of its Miami J Select cervical fixation device (Registration Certificate No.: 20181375). This action was initiated by the manufacturer, Ossur hf, due to a decision to update the safety and warning information contained within the product's instructions for use. The primary motivation for this update was to ensure compliance with the requirements set forth by Australian regulatory authorities.
The company recognized the importance of addressing potential risks and enhancing user clarity, aiming to simplify the selection and proper use of the device for patients. Consequently, Ossur Prosthetics & Orthotics (Shanghai) Co., Ltd., under the oversight of regulatory bodies such as the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration, decided to update the product instructions and issue a safety notice to all users. The voluntary recall signifies the company's commitment to patient safety and adherence to international regulatory standards, ensuring that updated safety information is disseminated effectively. Affected product details are available in the "Medical Device Recall Event Report Form."

Company: https://www.globalkeysolutions.net/companies/ossur-hf/9be3ac0d-96e0-4d5c-8a66-f6662c64282c/