# FDA recall Z-1118-2025

> **Medicrea International** · Class II · device recall initiated 2024-12-03.

## 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.

## 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

## Key facts

- **Recall number:** Z-1118-2025
- **Recalling firm:** Medicrea International
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-12-03
- **Report date:** 2025-02-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Rillieux La Pape, France

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1118-2025

## Citation

> AI Analytics. FDA recall Z-1118-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1118-2025. Source: US FDA. Licensed CC0.

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