Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported October 22, 2025
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
Complaint identified issue with AI surgical planning software that may result in implant malalignment and/or decrease range of motion.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Kico Knee Innovation Company recalled Brand Name: ARVIS Product Name: ARVIS" Shoulder Model/Catalog Number: IN-27300, Arvis S… - a moderate-severity action.
Brand Name: ARVIS Product Name: ARVIS" Shoulder Model/Catalog Number: IN-27300, Arvis S… was recalled by Kico Knee Innovation Company in October 22, 2025. Reason: Complaint identified issue with AI surgical planning software that may result in implant malalignment and/or…. Check the official notice for the remedy. Verify recall #Z-0145-2026 with the FDA Devices before acting.
The recall
Kico Knee Innovation Company issued this moderate-severity FDA Devices recall-Complaint identified issue with AI surgical planning software that may result in implant malalignment and/or….
- Moderate
- severity level
- Class II
- classification
- October 22, 2025
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0145-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
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 list the affected scope as 21 systems.
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.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
21 systems
Related Recalls
6
3 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.
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 |
| Firm location | Pymble |
| Affected scope | 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.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0145-2026) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
CPSC Moderate
Rowenta Recalls Cordless Vacuum Cleaners Due to Risk of Serious Injury from Fire and Burn Hazards
· 2026-07-02
CPSC Moderate
Daikin Comfort Technologies Manufacturing Recalls Amana Air Conditioners and Heat Pumps Due to Risk of Serious Injury f…
· 2026-06-25
CPSC Moderate
Arizer Solo III Portable Vaporizers Recalled Due to Fire and Burn Hazards; Risk of Serious Injury or Death; Imported by…
· 2026-06-18
FDA Devices Moderate
GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603-902, Product Code KSA; used i…
GE Medical Systems Information Technologies Inc · 2026-06-03
FDA Devices Critical
Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) BLOCK TRAY, Medline Kit…
Medline Industries, LP · 2026-06-03
Compare this recall with Rowenta Recalls Cordless Vacuum Cleaners Due to Risk of Ser… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported October 22, 2025. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.