Recall Z-1857-2025 ยท KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Onkos Surgical, Inc.
ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System
| Date | May 28, 2025 (initiated Sep 22, 2024) |
| Status | Open, Classified |
| Reason | Potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur. |
| Root cause | Nonconforming Material/Component |
| Action | Onkos Medical notified consignees via email on about 09/22/2024. Consignees were instructed to segregate and quarantine any product on hand immediately, complete and return the response form, and arrange for existing implants to be returned. |
| Quantity | 24 units |
| Distribution | US Nationwide distribution in the states of AZ, CA, FL, FL, MD, MO, NC, TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161520 | ELEOS Limb Salvage System Onkos Surgical, Inc., Oct 28, 2016 |