Severity
Moderate
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 s
Reported: October 22, 2025 Initiated: September 19, 2025 #Z-0145-2026 21 systems units
Kico Knee Innovation Company issued this FDA Devices recall on October 22, 2025. Classified as Moderate severity (Class II). Approximately 21 systems units are affected. The recall was issued because: Complaint identified issue with AI surgical planning software that may result in implant malalignment and/or decrease …. This recall notice is sourced from official FDA Devices enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.
Recall Insight
This FDA Devices action (record #Z-0145-2026) was formally reported on October 22, 2025, with the manufacturer initiating the action on September 19, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. Kico Knee Innovation Company is listed as the recalling firm, operating out of Pymble. Federal records indicate 21 systems units are affected.
The documented reason for this recall is: Complaint identified issue with AI surgical planning software that may result in implant malalignment and/or decrease range of motion. Distribution data in the federal record shows the product reached: US Nationwide distribution in the states of IN, MN, MO, OH, FL, IL, RI, KY, CA, WI, MI, PA, WA, CO, AL.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 1 year old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.
Recall Distribution by Severity Class
Units Affected
21 systems
Related Recalls
6
6 from same agency
Product Description
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 on the patient s CT reconstructed digital bone model and bony landmarks. The shoulder navigation application software then matches the patient s digital bone model and landmarks to the intraoperative landmarks registered by the surgeon, allowing an image-based navigation to follow. The surgeon uses the plan data as guidance to navigate and help position shoulder instruments and implants.
Reason for Recall
Complaint identified issue with AI surgical planning software that may result in implant malalignment and/or decrease range of motion.
Details
- Recalling Firm
- Kico Knee Innovation Company
- Units 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.
- Location
- Pymble
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0145-2026 |
| Date reported | October 22, 2025 |
| Date initiated | September 19, 2025 |
| Recalling firm | Kico Knee Innovation Company |
| Units 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
Frequently Asked Questions
What product was recalled? ▼
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 on the patient s CT reconstructed digital bone model and bony landmarks. The shoulder navigation application software then matches the patient s digital bone model and landmarks to the intraoperative landmarks registered by the surgeon, allowing an image-based navigation to follow. The surgeon uses the plan data as guidance to navigate and help position shoulder instruments and implants.. Recalled by Kico Knee Innovation Company. Units affected: 21 systems.
Why was this product recalled? ▼
Complaint identified issue with AI surgical planning software that may result in implant malalignment and/or decrease range of motion.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 22, 2025. Severity: Moderate. Recall number: Z-0145-2026.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution in the states of IN, MN, MO, OH, FL, IL, RI, KY, CA, WI, MI, PA, WA, CO, AL..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0145-2026) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Product recalls are issued when a manufacturer, distributor, or federal agency determines that a product poses a safety risk to consumers. This recall is classified as moderate severity, indicating the product may cause temporary or medically reversible health consequences. Across PlainRecalls, we track 83,000+ recalls from FDA, CPSC, and NHTSA to help consumers stay informed and act quickly when safety issues arise.
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Data Sources
Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
- Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- U.S. Census Bureau ACS — demographic + housing + income data. census.gov/programs-surveys/acs
- BLS Occupational Employment and Wage Statistics (OEWS) — wage + employment by occupation. bls.gov/oes
- BEA Regional Economic Accounts — GDP + personal income by state/metro. bea.gov/data/regional
- U.S. Census Bureau County Business Patterns — establishment + employment by industry. census.gov/cbp
- IRS Statistics of Income (SOI) — tax-return aggregate data. irs.gov/statistics
- data.gov — U.S. federal open-data portal — discovery layer for additional federal sources. data.gov
Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).