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

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.