Brand Name: Kico Knee Innovation Product Name: ARVIS SURGICAL NAVIGATION SYSTEM GEN 2 Model/Catalog Number: IN-29200 Sof

FDA device recall Z-2957-2026 · posted 2026-08-14 · Open, Classified

Recall details

Recalling firm

Kico Knee Innovation Company

Reason for recall

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

Action taken

On 07/13/2026, an "Urgent: Medical Device Recall (Correction)" Letter was email to customers informing them that, KICO has received complaints indicating that the image displayed within the ARVIS eyepiece may appear tilted relative to the eyepiece housing. The display tilt is a persistent condition rather than intermittent or periodic. When the issue occurs, the calibration parameters within an internal sensor change, resulting in a constant offset in the displayed orientation. Once this occurs, the display tilt is consistently present each time the device is powered on and used until the sensor is recalibrated and the firmware correction is implemented. Customers are instructed to: 1. Do not use the ARVIS Gen 2 Navigation System for any hip procedures. 2. The ARVIS Gen 2 Navigation System may continue to be used for Knee and Shoulder procedures only, but it is recommended that all units in inventory are turned on in advance of clinical use and that any units evidencing a tilted display be returned for replacement. 3. This notice needs to be passed on to all those who need to be aware within your organization or functions where the potentially affected devices have been transferred. 4. This notice must be physically posted on or near all ARVIS Gen 2 Navigation Systems. 5. Retain a copy of this letter, place a copy where devices are stored, and keep a copy of the acknowledgement form for your files. 6. Complete the attached Acknowledgement Form immediately and return it email to Alexander.Borchardt@enovis.com 7. The ARVIS Gen 2 Navigation System should always be visually inspected prior to use as stated in the Instructions for Use. 8. Inform KICO of any Adverse Events*/Serious Incidents** or quality problems concerning the use of the subject devices via the standard complaint process. For question - contact either Sr Product Manager at Jamie.reynolds@enovis.com (512) 451-3815 or Sr Director, Regulatory Affairs at Sherri.Mellingen@enovis.com (952) 913-6383

Root cause

Device Design

Status

Open, Classified

Product code

SBF

Quantity affected

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 VEN

Date initiated

2026-07-13

Date posted

2026-08-14

Location

Pymble, Australia

Related 510(k) clearances