Eleos Male-Female Midsection (Onkos Surgical) – Assembly Challenge (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System
Brand
Onkos Surgical, Inc.
Lot Codes / Batch Numbers
Part Number: 25001040E. UDI-DI B27825001040E0. Lot Numbers: 1989873, 1989874
Products Sold
Part Number: 25001040E. UDI-DI B27825001040E0. Lot Numbers: 1989873, 1989874
Onkos Surgical, Inc. is recalling ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System due to Potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026