FDA Medical devices recall ·
Arvis Hip & Knee 2.0 Instrument Set recall
- Recall number
- Z-2293-2026
- Date
- (initiated April 23, 2026)
- Company / brand
- Kico Knee Innovation Company
Suite 3, Building 1, 20 Bridge St, Pymble, Australia - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 124 kits
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
All Lots/serial Numbers; UDI: IN-28000: 00810180350020; IN-10500: (01)00810180350686; IN-10600 (01)00810180350693; IN-16400:(01)00810180350525; IN-16100: (01)00810180350563;
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.
States: Alabama Arizona California Colorado Florida Iowa Idaho Illinois Indiana Kansas Massachusetts Maryland Michigan Minnesota Mississippi Montana Nebraska New Hampshire New Jersey New York Oregon Pennsylvania Puerto Rico Rhode Island Tennessee Virginia Vermont Washington Wisconsin
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2293-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.