Class II — Kico Knee Innovation Company
| Recalling firm | Kico Knee Innovation Company |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Due to an internal sensor issue, image displayed with eyepiece may appear tilted relative to the eyepiece housing |
| 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 ref… |
| Quantity | 78 |
| Distribution | Consignee Consignee Number Region Device Quantity RFK MEDICAL CE102 RICHMOND VA IN-29200, ARVIS SURGICAL NAVIGATION 1 VALOR MEDICAL CE118 SAN ANTONIO TX IN-29200, ARVIS SURGICAL NAVIGATION 2 JOINT VENTURES MEDICAL CE121 OSHKOSH WI IN-29200, ARVIS SURGICAL NAVIGATION 1 CASTLE MEDICAL CE122 WATERLOO IA IN-29200, ARVIS SURGICAL NAVIGATION 6 GREAT LAKES MEDICAL GL108 NAPERVILLE IL IN-292… |
| Initiated | 2026-07-13 |
| Classified | 2026-08-14 |
| Recall number | Z-2957-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Kico Knee Innovation Company (Z-2957-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99372/
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