Brand Name: ARVIS Product Name: ARVIS" Shoulder Model/Catalog Number: IN-27300, Arvis Surgical Planning Software Softwar
FDA device recall Z-0145-2026 · posted 2025-10-14 · Open, Classified
Recall details
- Recalling firm
- Kico Knee Innovation Company
- Reason for recall
- Complaint identified issue with AI surgical planning software that may result in implant malalignment and/or decrease range of motion.
- Action taken
- On September 12, 2025, Kico Knee Innovation Company issued a recall notice to affected consignees. Kico asked consignees to take the following actions: 1. No actions are required by the surgeon users. 2. For the plans affected, Kico has quarantined these as they are not suitable for clinical use. 3. A long-term solution has been implemented to return the system to the specification of the most recently cleared device. We will contact surgeon users to login and re-plan their cases for upcoming surgeries.
- Root cause
- Software change control
- Status
- Open, Classified
- Product code
- SBF
- Quantity affected
- 21 systems
- Distribution
- US Nationwide distribution in the states of IN, MN, MO, OH, FL, IL, RI, KY, CA, WI, MI, PA, WA, CO, AL.
- Date initiated
- 2025-09-19
- Date posted
- 2025-10-14
- Location
- Pymble, Australia
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARVIS® Shoulder (K243950) | Kico Knee Innovation Company Pty, Ltd. | 2025-01-13 |