Reported Feb 12, 2025 · Ongoing
UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI code 03613720286929 Two cloud-based…
Medicrea International
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medicrea International · 5389 route de Strasbourg · Rillieux La Pape · N/A
Is this the product you have?
- 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
- Lot codes and dates
- UNiD HUB is not a medical device and thus does not have a CFN or GTIN code. UNiD Spine Analyzer
- Product Number SW3002 UDI-DI code03613720286929 No lot numbers
- Amount recalled
- 1,548 users
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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