Lower risk Medical device recall · FDA · Published December 3, 2024

Medicrea UNiD Spine Analyzer Software Error Recall: Incorrect Surgical Calculations

Medicrea recalls UNiD Spine Analyzer software (SW3002) due to potential errors in surgical planning calculations. Affected users should contact for remedy.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1118-2025Medical device Medicrea ›

Lower-risk 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.

Take action

Contact the company

Recalling firmMedicrea International5389 route de Strasbourg, Vancia · Rillieux La Pape, France

✎ GovInfoNow plain-language explainer

Medicrea is recalling its UNiD Spine Analyzer software (product number SW3002) because software anomalies could lead to incorrect surgical calculations. This might affect spinal surgery planning accuracy, though no injuries have been reported. Read more at govinfonow.com/recall/53337-medicrea-unid-spine-analyzer-software-error-recall-incorrect-surgical-calculations.

Source Summary by GovInfoNow · govinfonow.com/recall/53337-medicrea-unid-spine-analyzer-software-error-recall-incorrect-surgical-calculations · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1118-2025

Cite this page

“Medicrea UNiD Spine Analyzer Software Error Recall: Incorrect Surgical Calculations.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53337-medicrea-unid-spine-analyzer-software-error-recall-incorrect-surgical-calculations. Based on FDA recall #Z-1118-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1118-2025%22&limit=1).

The FDA announced on Dec. 3, 2024, that Medicrea International is recalling the UNiD Spine Analyzer (Product Number SW3002) due to software anomalies causing incorrect surgical calculations. The agency said the recall affects 1,548 users in the U.S. and abroad.

How to tell if you have it

Medicrea
UNiD Spine Analyzer
Product Number SW3002
UDI-DI code 03613720286929

The hazard

The FDA said certain optional surgical parameters may have errors resulting in incorrect calculations displayed on the system. Impacted parameters include Roussouly Classification, Real Lumbar Lordosis and Real Thoracic Kyphosis, Barrey Ratio, and Lenke Classification.

Context

GovInfoNow's records show Medicrea International has issued eight other recalls since June 27, 2019. Recent brand recalls include the Oct. 29, 2025, IB3D Universal Implant Inserter recall for handle untreading and the July 12, 2023, IMPIX MANTA spinal fusion device recall for packaging pinhole risks. Other recent recalls of similar products include the InteleShare Software Recall (Nov. 18, 2025), the Mazor X Robotic System Software Errors Risk Incorrect Spinal Surgery (Dec. 10, 2025), and the Merge PACS Workstation Software Inaccurate Measurements - Recall (July 22, 2026).

How to tell if you have this one

The UNiD Spine Analyzer software (product number SW3002) with UDI-DI code 03613720286929. This software is used for spinal surgery planning and is cloud-based.

Brand
Medicrea
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Contact Medicrea
Reach out to Medicrea International for guidance on the recall and potential remedies.

Where it went and when

Where it was distributed

Distributed in 48 states and D.C. and Puerto Rico, and outside the U.S.

FDA 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…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 2 months after the firm started it.

Dec 3, 2024Firm started the recall
Feb 6, 2025FDA classified it Class II
Feb 12, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/53337-medicrea-unid-spine-analyzer-software-error-recall-incorrect-surgical-calculations">Medicrea UNiD Spine Analyzer Software Error Recall: Incorrect Surgical Calculations (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1118-2025 (December 3, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1118-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.