Recall Z-2292-2026 ยท OLO Orthopedic Stereotaxic Instrument
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 , Tracker B; IN-16400, Tracker A; IN-16100, Tracker C; IN-28050, Tracker E
| Date | Jun 2, 2026 (initiated Apr 23, 2026) |
| Status | Open, Classified |
| 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. |
| Root cause | Device Design |
| Action | On April 27, 2026 Kico Knee Innovation issued a Urgent: Medical Device Recall to affected consignees via E-Mail. Kico ask consignees to take the following actions: 1. Instruments can continue to be used as is, given none of the failure modes are exhibited. 2. This notice needs to be passed on to all those who need to be aware within your organization or where the potentially affected devices have been transferred. 3. Please retain a copy of this letter, place a copy where devices are stored, and keep a copy of the acknowledgement form for your files. 4. Complete the attached Acknowledgement |
| Quantity | 69 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K203115 | ARVIS Surgical Navigation System Insight Medical Systems, Inc., Jul 14, 2021 |