Brand Name: Kico Knee Innovation Product Name: ARVIS SURGICAL… — Class II medical device recall Z-2957-2026
Ongoing recall by Kico Knee Innovation Company, reported 2026-08-26, distributed in AZ, CA, FL, IA, IL, IN, KS, KY…. Due to an internal sensor issue, image displayed with eyepiece may appear tilted relative to the eyepiece hous
| Recall number | Z-2957-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Kico Knee Innovation Company, Pymble, Australia |
| Recall initiated | 2026-07-13 |
| Classified | 2026-08-14 |
| Reported by FDA | 2026-08-26 |
| Distributed | AZ, CA, FL, IA, IL, IN, KS, KY, NY, PR, RI, TX, WI |
| Quantity | 78 |
| UPC / GTIN / UDI-DI | 00810180351287 |
| Serial numbers | 6006A1010C2, 6006A1011C2, 6006A1024C2, 6006A1025C2, 6006A1027C2, 6006A1030C2, 6006A1034C2, 6006A1035C2, 6006A1036C3, 6006A1037C2, 6006A1040C2, 6006A1041C2, 6006A1042C2, 6006A1044C2, 6006A1045C2, 6006A1046C2, 6006A1052C2, 6006A1053C3, 6006A1057C2, 6006A1058C3, 6006A1059C3, 6006A1060C3, 6006A1064C, 6006A1068C, 6006A1071C2 and 51 more |
| Model numbers | IN-29200 |
Product
Brand Name: Kico Knee Innovation Product Name: ARVIS SURGICAL NAVIGATION SYSTEM GEN 2 Model/Catalog Number: IN-29200 Software Version: ARVIS Hip and Knee Gap Balance Software v3.3.2 (IN-28200) ARVIS Shoulder Software v2.0.3 (IN-23630) Product Description: 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. The ARVIS Surgical Navigation System is indicated for assisting the surgeon in the positioning and alignment of implants relative to reference alignment axes and landmarks in stereotactic orthopedic surgery. The system aids the surgeon in making intraoperative measurements such as changes in leg length in Hip Arthroplasty. The system is compatible with straight acetabular impactors and with specific offset impactors, identified in the instructions for use, for which an adapter has been validated. Example orthopedic surgical procedures include but are not limited to: " Total Knee Arthroplasty " Unicompartmental Knee Arthroplasty: Tibial Transverse Resection " Hip Arthroplasty The ARVIS" head mounted display is for displaying augmented reality visualization and information to the user intraoperatively. The augmented/virtual displayed information should not be relied upon solely for absolute positional/alignment information and should always be used in conjunction with the displayed stereotaxic information. Component: NA
Reason for recall
Due to an internal sensor issue, image displayed with eyepiece may appear tilted relative to the eyepiece housing
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2957-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.