Class 2 Device Recall UNiD" Adaptive Spine Intelligence

• Date Initiated by Firm: December 03, 2024
• Date Posted: February 07, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1118-2025
• Recall Event ID: 95957
• 510(K)Number: K212005
• Product Classification: System, image processing, radiological - Product Code LLZ
• Product: UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI code 03613720286929 Two cloud-based software applications within UNiD Adaptive Spine Intelligence (ASI): the UNiD HUB and the UNiD Spine Analyzer. The UNiD HUB cloud-based software is a healthcare application to receive, transfer, display, store data needed for planning a spine surgery or for post-operative follow-up (patient information, X-ray image and recommendations for planning). The UNiD Spine Analyzer cloud based software is a healthcare application intended for assisting healthcare professionals in viewing and measuring images as well as planning spine surgeries.
• Code Information: UNiD HUB is not a medical device and thus does not have a CFN or GTIN code. UNiD Spine Analyzer Product Number SW3002 UDI-DI code: 03613720286929 No lot numbers
• FEI Number: 1000432246
• Recalling Firm/ Manufacturer: Medicrea International; 5389 route de Strasbourg; Vancia; Rillieux La Pape France
• For Additional Information Contact: Medtronic Customer Service; 800-962-9888
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Software design
• Action: 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.
• Quantity in Commerce: 1,548 users
• Distribution: U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. O.U.S.: Argentina Australia Belgium Brazil Bulgaria Chile Czech Republic Denmark Finland France Germany Greece Iceland Ireland Israel Italy Luxembourg Malaysia Mexico Monaco Morocco Netherlands New Zealand Poland Portugal Singapore South Korea Spain Sweden Switzerland United Kingdom
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = LLZ