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

Recall Z-0145-2026 — Brand Name: ARVIS Product Name: ARVIS" Shoulder Model/Catalog Number: IN-27300, Arvis Surgical Planning Software Software Version: V2025.1.2 Product Description: Intended Use: The ARVIS" system is a computer-controlled navigation system intended to provide intra-operative measurements to the sur

U.S. FDA — Device Enforcement · Australia · 2025-09-19 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0145-2026
Date of alert: 2025-09-19
Country / jurisdiction: Australia
Risk level: Class II
Risk type: recall
Brand: Kico Knee Innovation Company
Product category: device
Product type: Devices

Reported risk: Complaint identified issue with AI surgical planning software that may result in implant malalignment and/or decrease range of motion.

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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