# FDA recall Z-0145-2026

> **Kico Knee Innovation Company** · Class II · device recall initiated 2025-09-19.

## Product

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 surgeon to aid in selection and positioning of orthopedic implant components.      Description: ARVIS Shoulder is a computer-controlled surgical navigation system for shoulder arthroplasty. It aids the surgeon in making intra-operative measurements and locating anatomical structures of the shoulder joint based on the patient s preoperative imaging to assist with selection and positioning of orthopedic implant components. The system consists of software, electronic hardware and surgical instruments.     The device s workflow involves CT based preoperative planning followed by intraoperative navigation and execution. The preoperative planning software enables 3D virtual implant positioning based 

## Reason for recall

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

## Distribution

US Nationwide distribution in the states of IN, MN, MO, OH, FL, IL, RI, KY, CA, WI, MI, PA, WA, CO, AL.

## Key facts

- **Recall number:** Z-0145-2026
- **Recalling firm:** Kico Knee Innovation Company
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-09-19
- **Report date:** 2025-10-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Pymble, Australia

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0145-2026

## Citation

> AI Analytics. FDA recall Z-0145-2026. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0145-2026. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*