FDA recall Z-2293-2026

Kico Knee Innovation Company · Class II · device

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 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.

Distribution

Worldwide - US Nationwide distribution in the states of MS, CA, IA, IN, MI, CO, MT, FL, IL, NY, AL, WI, NE, AZ, MN, VT, NH, MD, RI, MA, NJ, PA, KS, WA, ID, OR, TN, VA, PR and the countries of Australia, France, Germany, Italy.

Key facts

Status
Ongoing
Initiation date
2026-04-23
Report date
2026-06-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Pymble, Australia

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2293-2026