Kico Knee Innovation Company: Orthopedic Stereotaxic Instrument
Kico Knee Innovation Company is recalling certain components of the Arvis Hip & Knee 2.0 Instrument Set used in orthopedic surgery because the Impactor V-Block Assembly and Trackers may show early wear and corrosion on the magnet surfaces. The recall affects medical facilities in the United States, Australia, France, Germany, and Italy that received these surgical instruments. This is a Class II recall, indicating a potential health hazard, though the company has not reported any injuries.
- Recalling firm
- Kico Knee Innovation Company
- 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
- 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.
- 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/9984019d-cd3d-4bc7-b9b0-9b6c49890ba4