UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number… — Class II medical device recall Z-1118-2025
Ongoing recall by Medicrea International, reported 2025-02-12, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. Due to software anomalies that may impact on rod planning specifically, certain optional surgical parameters m
| Recall number | Z-1118-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medicrea International, Rillieux La Pape, France |
| Recall initiated | 2024-12-03 |
| Classified | 2025-02-06 |
| Reported by FDA | 2025-02-12 |
| Distributed | 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, WY |
| Countries outside the US | AR, AU, BE, BG, BR, CH, CL, CZ, DE, DK, ES, FI, FR, GB, GR, IE, IL, IS, IT, KR, LU, MA, MX, MY, NL, NZ, PL, PT, SE, SG |
| Quantity | 1,548 users |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 03613720286929 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1118-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.