Medicrea International has recalled approximately 1,548 units of its UNiD Adaptive Spine Intelligence software suite, including the UNiD HUB and the UNiD Spine Analyzer (Product Number SW3002). The recall was initiated due to software errors that can result in incorrect surgical calculations for parameters such as the Roussouly Classification, Barrey Ratio, and spinal curvature measurements. These anomalies specifically impact the planning of spinal rods used in surgery. No injuries or incidents have been reported to date.
Incorrect surgical calculations can lead to improper rod planning or spinal alignment during surgery. This poses a risk of suboptimal surgical outcomes for patients or may necessitate corrective surgical procedures.
The UNiD HUB is a cloud-based software application that does not have a CFN or GTIN code. Software anomalies impact surgical parameters used for rod planning.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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