Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1118-2025 — 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

U.S. FDA — Device Enforcement · France · 2024-12-03 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1118-2025
Date of alert: 2024-12-03
Country / jurisdiction: France
Risk level: Class II
Risk type: recall
Brand: Medicrea International
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 03613720286929

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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