Medicrea International Recall: UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Produ
Medicrea International Recall: UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Produ is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Medicrea International; Product: UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI code 03613720286929 Two cloud-b
| Recalling firm | Medicrea International |
|---|---|
| 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 viewi |
| 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Ongoing |
| 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 F |
| Recall initiated | 20241203 |
| Recall number | Z-1118-2025 |
| Category | device |
| Country | France |
$29/mo
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