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Recall Observatory FDA recall evidence

Device 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

Z-2292-2026

April 23, 2026

Class II

Product summary

Firm
Kico Knee Innovation Company
Event
Event 98804
Status
Ongoing
Classification
Class II
Quantity
69 units
Official record key
device-enforcement:Z-2292-2026

Official wording

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.

Code information: All Lots/serial Numbers; UDI: IN-28000: 00810180350020; IN-10500: (01)00810180350686; IN-10600 (01)00810180350693; IN-16400:(01)00810180350525; IN-16100: (01)00810180350563; IN-28050: 00810180350051

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.