FDAFDA · Food and drugs·Recall number Z-2292-2026
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
Published June 10, 2026 · Recall initiated: April 23, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Kico Knee Innovation Company
- Distributor
- 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.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Australia
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