Medicrea International 2025-02-12 Health serious FDA
Health · FDA · Recall #FDA-Z-1118-2025
UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI… Recall
Issued February 12, 2025 · Medicrea International
In February 2025, Medicrea International recalled the UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Medicrea International to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Medicrea International
- Category
- Health
- Recall date
- February 12, 2025
- Units affected
- Not reported
- Sold at
- 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
- Recall number
- FDA-Z-1118-2025
- Made in
- France
- Issuing agency
- FDA
In context
- Medicrea International has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.