Recall Z-2293-2026— Kico Knee Innovation Company

Name: FDA recall Z-2293-2026
Creator: U.S. Food and Drug Administration
Published: 2026-04-23

Class II · Ongoing

Class II FDA medical device recall by Kico Knee Innovation Company, initiated 2026-04-23. It names one FDA 510(k) clearance: K203115. Product: Arvis Hip & Knee 2.0 Instrument Set, REF: IN-21200 containing one of the following components: IN-10500, Impactor V-Block Assembly; IN-10600 , Tracker B; IN-16400, Tracker A; IN-16100, Tracker C. Reason: The Impactor V-Block Assembly and Trackers A, B, C and E may exhibit signs of early wear and/or corrosion on the exposed magnet face..

Recalling firm: Kico Knee Innovation Company
Classification: Class II
Status: Ongoing
Initiated: 2026-04-23
Firm location: Pymble, Australia

510(k) clearances named in this recall

1 on FDA's record

K203115 — ARVIS Surgical Navigation SystemInsight Medical Systems, Inc.·cleared 2021-07-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Arvis Hip & Knee 2.0 Instrument Set, REF: IN-21200 containing one of the following components: IN-10500, Impactor V-Block Assembly; IN-10600 , Tracker B; IN-16400, Tracker A; IN-16100, Tracker C

Reason for recall

The Impactor V-Block Assembly and Trackers A, B, C and E may exhibit signs of early wear and/or corrosion on the exposed magnet face.

Data sourced from openFDA. This site is unofficial and independent of the FDA.