Recall Z-1857-2025
Onkos Surgical, Inc. · initiated September 22, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System
Codes / lots: Part Number: 25001040E. UDI-DI B27825001040E0. Lot Numbers: 1989873, 1989874
Reason for recall
Potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur.
FDA-determined cause: Nonconforming Material/Component
Action taken
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.
Details
- Recall number
- Z-1857-2025
- Initiated
- September 22, 2024
- Posted by FDA
- May 28, 2025
- Product code
- KRO – Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
- Quantity
- 24 units
- Distribution
- US Nationwide distribution in the states of AZ, CA, FL, FL, MD, MO, NC, TN.
- Recalling firm
- Onkos Surgical, Inc., Parsippany, NJ