Kico Knee Innovation Company: Orthopedic Stereotaxic Instrument
Kico Knee Innovation Company is recalling certain components of the Arvis Hip & Knee 3.0 Instrument Set used in orthopedic surgery because the V-Block Assembly and Trackers may show early wear and corrosion on the magnet surface. The recall affects devices distributed nationwide in the US and internationally in Australia, France, Germany, and Italy. This is classified as a Class II recall, indicating a potential health risk that is unlikely to result in serious injury or death.
- Recalling firm
- 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
- 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
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-04-23
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- 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.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/89ac2a21-3c49-474e-9919-0b70aca8b419