Recall Z-2292-2026— Kico Knee Innovation Company
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 3.0 Instrument Set, REF: IN-28000 containing one of the following components: IN-10500, Impactor V-Block Assembly; IN-10600 , Tracker B; IN-16400, Tracker A; IN-16100, Tracker C; IN-28050, Tracker E. Reason: The 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 recordK-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 3.0 Instrument Set, REF: IN-28000 containing one of the following components: IN-10500, Impactor V-Block Assembly; IN-10600 , Tracker B; IN-16400, Tracker A; IN-16100, Tracker C; IN-28050, Tracker E
Reason for recall
The 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.