# China NMPA Product Recall - Neck brace (product name: Miami JSelect)

Source: https://www.globalkeysolutions.net/records/china_product_recall/ossur-hf/50992826-0fda-4ec2-a4ff-eadd2b4bef03/
Source feed: China

> China NMPA product recall for Neck brace (product name: Miami JSelect) by Ossur hf published June 08, 2021. Recall level: Level 2 Recall. The National Medical Products Administration (NMPA) announced a voluntary Class II recall initiated 

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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: 2021-06-08
- Product Name: Neck brace (product name: Miami JSelect)
- Recall Level: Level 2 Recall
- Recall Reason: Because the Miami J Select from the affected batches may deform under certain circumstances, it may lead to a reduction in the fixation strength for the cervical spine.
- Discovering Company: Ossur hf
- Manufacturing Company: Ossur hf
- Summary: The National Medical Products Administration (NMPA) announced a voluntary Class II recall initiated by Ossur Prosthetics & Orthotics (Shanghai) Co., Ltd., on June 8, 2021. This action concerns their neck fixation device, specifically the Miami J Select model (registration certificate number: 

国械备20181375号). The recall was prompted by concerns from the parent company, Ossur hf, regarding a critical product defect.

The primary issue identified is the potential for certain batches of the Miami J Select devices to deform under specific conditions. This deformation risk is significant because it can lead to a reduction in the device's ability to provide adequate cervical spine fixation strength. Such a compromise in performance poses a potential safety risk to patients relying on the device for neck support and stabilization.

Under the NMPA's oversight, Ossur Prosthetics & Orthotics (Shanghai) Co., Ltd., is undertaking this recall to address the product's non-conformity. Detailed information regarding the affected product models, specifications, and batch numbers is available in the "Medical Device Recall Event Report Form," which customers and healthcare providers can access. This voluntary recall emphasizes the manufacturer's responsibility to ensure product safety and effectiveness in accordance with regulatory expectations.

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