Kico Knee Innovation Company: Arvis Hip & Knee 3.0 Instrument Set, REF: IN-28000 containing one of the following components: IN-10500, Impactor V-Block Assembly; IN-10600
Read the official notice at FDA (device) →
Get alerts for Kico Knee Innovation
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Kico Knee Innovation Company
- 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 / 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- 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.
- Recall initiated
- 2026-04-23
- Code info
- 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
- Product quantity
- 69 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Pymble
- Country
- Australia
- Event id
- 98804
Free daily digest + "My products" watchlist