FDA Medical Device Recalls (openFDA)
Onkos Surgical, Inc.: ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System
- Recall number
- Z-1857-2025
- Recalling firm
- Onkos Surgical, Inc.
- Product
- ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System
- Status
- Open, Classified
- Initiated
- 2024-09-22
- Posted
- 2025-05-28
- Terminated
- not on file
- 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.
- Lot, serial or model codes
- Part Number: 25001040E. UDI-DI B27825001040E0. Lot Numbers: 1989873, 1989874
- 510(k) numbers
- ["K161520"]
- PMA numbers
- not on file
- Product code
- KRO
- Firm FEI
- 3013450937
- Firm city
- Parsippany
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28