Class II U.S. Food and Drug Administration

Brand Name: Kico Knee Innovation Product Name: Arvis Surgical recall: Due to an internal sensor issue, image displayed with eyepiece may appear

Recall published 2 months ago

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

The hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

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

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-2957-2026
Published
August 26, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Kico Knee Innovation Company
Product type
Medical devices
Units affected
78
Distribution
Alabama, Arizona, California, Colorado, Florida, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Nebraska, New York, Puerto Rico, Rhode Island, South Carolina, Texas, Virginia, Washington, Wisconsin
Sold at
Gap
Made in
Australia
Lot / code info
Lot Code: GMDN - 45200 UDI-DI - 00810180351287 Software ARVIS Hip and Knee Gap Balance Software v3.3.2 (IN-28200) ARVIS Shoulder Software v2.0.3 (IN-23630) Serial Number 6006A1118 6006A1036C3 6006A1117 6006A1045C2 6006A1106 6006A1126 6006A1149 6006A1034C2 6006A1046C2 6006A1086C2 6006A1093 6006A1079C3 6006A1096C2 6006A1052C2 6006A1058C3 6006A1030C2 6006A1088 6006A1100C 6006A1094 6006A1041C2 6006A1060C3 6006A1092C 6006A1105 6006A1140 6006A1040C2 6006A1090 6006A1116 6006A1109 6006A1037C2 6006A1053C3 6006A1102 6006A1108 6006A1120 6006A1155 6006A1127 6006A1139 6006A1095C2 6006A1131 6006A1132 6006A1142 6006A1152 6006A1193 6006A1194 6006A1208 6006A1209 6006A1107 6006A1064C 6006A1068C 6006A1081C 6006A1011C2 6006A1104 6006A1101 6006A1087C 6006A1075C 6006A1035C2 6006A1057C2 6006A1044C2 6006A1024C2 6006A1059C3 6006A1083C3 6006A1119 6006A1124 6006A1128 6006A1071C2 6006A1089 6006A1084 6006A1042C2 6006A1078C2 6006A1082C2 6006A1027C2 6006A1010C2 6006A1125 6006A1147 6006A1025C2 6006A1077C 6006A1076C
UPC codes
00810180351287

Products covered by this recall

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

Check your product

The notice names 3 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00810180351287

Model or item number

On the rating label, the box or the instruction sheet.

  • IN-29200 Software Version

Serial number

On the rating plate, often next to the date of manufacture.

  • 6006A1118 6006A1036C3 6006A1117 6006A1045

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Kico Knee Innovation Company — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Company contact: Kico Knee Innovation Company — Suite 3, Building 1, 20 Bridge St, Pymble

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Kico Knee Innovation Company medical devices recalled?

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

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00810180351287; model number IN-29200 Software Version. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Which states were affected?

The notice lists Alabama, Arizona, California, Colorado, Florida, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Nebraska and others.

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