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FDA · Medical devices ·

Kico Knee Innovation Product Name recall

Kico Knee Innovation Company recalled Kico Knee Innovation Product Name on August 26, 2026 because of due to an internal sensor issue, image displayed with eyepiece may appear tilted relative to the eyepiece housing. It was sold in VA, IN, TX, WI, IA, IL, KY, SC, CO, RI, NY, NE, CA, KS, PR, AL, FL, AZ, HI, WA.

Why it was recalled

Due to an internal sensor issue, image displayed with eyepiece may appear tilted relative to the eyepiece housing

What's recalled

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 alignm…

Quantity: 78

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
Kico Knee Innovation Company, Pymble
Date
Severity
Class II
the product could cause temporary or reversible health problems.
Where sold
VA, IN, TX, WI, IA, IL, KY, SC, CO, RI, NY, NE, CA, KS, PR, AL, FL, AZ, HI, WA
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…
Status
Ongoing
Recall number
Z-2957-2026
Source
U.S. Food and Drug Administration

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