Medicrea International recalls UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI c…

Due to software anomalies that may impact on rod planning specifically, certain optional surgical parameters may have had errors that resulted i incorrect calculations displayed on system. Impacted parameters includes the following: Roussouly Classification, Real Lumbar Lordosis and Real Thoracic Kyphosis, Barrey Ratio, and Lenke Classification.

On 12/03/2024, Medtronic sent an "Urgent Medical Device Correction" notification to physician users of the UNiD HUB informing them of a software anomalies in the UNiD" HUB that may have impacted UNiD rod planning and certain optional surgical parameters (Roussouly Classification, Real Lumbar Lordosis and Real Thoracic Kyphosis, Barrey Ratio, and Lenke Classification), and may have errors that resulting in incorrect calculations displayed in the UNiD" HUB. Medtronic is also informing users of a Software update that has removed the impacted parameters. The software update was released on 12/03/2024. Customer are informed of Patient Management Recommendations: If a UNiD rod was planned without any of these four parameters and met the surgeons planned surgical objectives, no additional actions are required. As these parameters are optional for planning, there is no record of whether the parameters were utilized for surgical planning. If you are concerned that the use of these parameters may have adversely impacted a patient s sagittal balance, it is recommended to re-evaluate the surgical plan and continue to follow the patient based on your assessment of their post operative sagittal balance. Monitor patients per routine standard of care and intervene per medical judgement. Customer are instructed to: " Review this information within this letter " Healthcare providers may continue to use the UNiD HUB as instructed in the External User Guide. " Confirm via the enclosed confirmation form that this notification has been communicated within their facility with all physician users. Send the completed Customer Confirmation Form to Medtronic viaemail at neuro.quality@medtronic.com " This notice needs to be passed on to those who need to be aware within their organization that utilizes the UNiD HUB for planning and to maintain a copy of this notice in their records.

• FDA enforcement recordOfficial FDA database entry for Z-1118-2025
• FDA 510(k) clearance · K212005The device's official FDA premarket clearance record
• FDA device classification · LLZOfficial FDA classification for this device type
• CFR regulation · 21 CFR 892.2050The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Medicrea InternationalSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.