The Recall Desk
HighFDA (Devices)·Z-1118-2025·Announced 2025-02-12

Spine Surgery Planning Software Calculation Errors in Rod Planning Parameters

Medicrea International is recalling UNiD Spine Analyzer software due to calculation errors in rod planning parameters. The software experienced anomalies resulting in incorrect values for surgical classification and measurement parameters used in spine surgery planning.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II medical device software recall with no reported injuries or illnesses. The hazard involves calculation errors in surgical planning parameters, representing a risk-of-harm product where injury has not yet been reported, consistent with High severity per the FDA rubric.

Plain-English summary

Medicrea International is recalling the UNiD Spine Analyzer, a cloud-based software application within UNiD Adaptive Spine Intelligence (ASI) used by healthcare professionals to view and measure medical images and assist in planning spine surgeries.

The recall is due to software anomalies affecting rod planning calculations. Certain optional surgical parameters contained errors that resulted in incorrect values being displayed. The affected parameters include Roussouly Classification, Real Lumbar Lordosis, Real Thoracic Kyphosis, Barrey Ratio, and Lenke Classification.

Approximately 1,548 users of the software are affected. The software has been distributed throughout the United States (all 50 states, the District of Columbia, and Puerto Rico) and internationally to 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, and the United Kingdom.

The recalled product

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 he
Manufacturer
Medicrea International
Category
Medical Device — Surgical Planning Software
Hazard
  • calculation-error
  • surgical-planning-error

Distribution

Distributed in 50 states:

  • 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

Related recalls

Same category