FDA recall, , Moderate risk
Kico Knee Innovation Arvis Surgical Navigation System GEN 2
The ARVIS surgical navigation system may show a tilted image due to an internal sensor issue.
Summary by Recall Canary from the FDA notice
What happened
Kico Knee Innovation Company, of Pymble, Australia, began a recall of the Arvis Surgical Navigation System GEN 2 on July 13, 2026, because an internal sensor issue may cause the image displayed with the eyepiece to appear tilted relative to the eyepiece housing. The system, a computer-controlled navigation device for intra-operative measurements, was added to the FDA's Enforcement Report and classified on August 14, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the model number and lot code listed under your product.
Arvis Surgical Navigation System GEN 2
- Model number
- IN-29200
- Lot code
- 45200
Recall details
- Company began the recall
- Sold in
- 19 states
Consignee Consignee Number Region Device Quantity RFK MEDICAL CE102 RICHMOND Virginia IN-29200, ARVIS SURGICAL NAVIGATION 1 VALOR MEDICAL CE118 SAN ANTONIO Texas IN-29200, ARVIS SURGICAL NAVIGATION 2 JOINT VENTURES MEDICAL CE121 OSHKOSH Wisconsin IN-29200, ARVIS SURGICAL NAVIGATION 1 CASTLE MEDICAL CE122 WATERLOO Iowa IN-29200, ARVIS SURGICAL NAVIGATION 6 GREAT LAKES MEDICAL GL108 NAPERVILLE Illinois IN-29200, ARVIS SURGICAL NAVIGATION 2 CERTUS MEDICAL GL112 INDIANAPOLIS IN Indiana-29200, ARVIS SURGICAL NAVIGATION 5 I&S MEDICAL GL113 LOUISVILLE Kentucky IN-29200, ARVIS SURGICAL NAVIGATION 2 PROCORE MEDICAL MA102 PIEDMONT South Carolina IN-29200, ARVIS SURGICAL NAVIGATION 1 FOX MEDTECH MW001 ENGLEWOOD Colorado IN-29200, ARVIS SURGICAL NAVIGATION 2 MEDSOURCE Nebraska131 TIVERTON Rhode Island IN-29200, ARVIS SURGICAL NAVIGATION 4 IMPLANT MEDICAL SALES Nebraska190 HICKSVILLE New York IN-29200, ARVIS SURGICAL NAVIGATION 2 KINETIC MEDICINE NW105 OMAHA Nebraska IN-29200, ARVIS SURGICAL NAVIGATION 4 CALSURG NW115 SANTA BARBARA California IN-29200, ARVIS SURGICAL NAVIGATION 4 MIDWEST MEDICAL RESOURCES South Carolina181 OVERLAND PARK Kansas IN-29200, ARVIS SURGICAL NAVIGATION 3 ORTHO & SURGICAL SOLUTIONS SE175 GUAYNABO PR IN-29200, ARVIS SURGICAL NAVIGATION 3 JOINT MEDICAL SOLUTIONS SE180 BIRMINGHAM Alabama IN-29200, ARVIS SURGICAL NAVIGATION 4 FLT ORTHOPEDICS SE216 TAMPA Florida IN-29200, ARVIS SURGICAL NAVIGATION 6 MAC MEDICAL W180 GILBERT Arizona IN-29200, ARVIS SURGICAL NAVIGATION 1 CP ORTHO W214 HONOLULU HI IN-29200, ARVIS SURGICAL NAVIGATION 1 UNIFIED ORTHOPEDICS W223 RIVERSIDE California IN-29200, ARVIS SURGICAL NAVIGATION 18 MOVEMENT MEDICAL W225 SEATTLE Washington IN-29200, ARVIS SURGICAL NAVIGATION 6 Total number of devices in the field 78
- Company
- Kico Knee Innovation CompanyPymble, Australia
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99372
- Recall number
- Z-2957-2026
All recalls from Kico Knee Innovation Company
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
