ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E recallZ-1857-2025 · Onkos Surgical, Inc. · initiated Sep 22, 2024
Class II Open, Classified All recalls posted in May 2025
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Onkos Surgical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-1857-2025
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Sep 22, 2024
- Posted by the FDA
- May 28, 2025
- Recalling firm
- Onkos Surgical, Inc.
- Quantity
- 24 units
- Product code
- KRO
- FDA submissions
- K161520
- Distribution
- US Nationwide distribution in the states of AZ, CA, FL, FL, MD, MO, NC, TN.
Product description
ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System
Code information (models, lots, serial numbers)
Part Number: 25001040E. UDI-DI B27825001040E0. Lot Numbers: 1989873, 1989874
Other devices under the same FDA submission
157 devices cleared under K161520 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ELEOS™ 25002111EOnkos Surgical, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented3 deaths230 reports
- ELEOS™ 25001208EOnkos Surgical, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER3 deaths193 reports
- ELEOS™ THSMWRS01MOnkos Surgical, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER190 reports
- ELEOS™ 25000007EOnkos Surgical, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 death86 reports
- ELEOS™ 25002100EOnkos Surgical, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER4 deaths83 reports
- ELEOS™ 25000009EOnkos Surgical, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER2 deaths73 reports
- ELEOS™ 25001040EOnkos Surgical, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented2 deaths68 reports
- ELEOS™ 25001210EOnkos Surgical, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented43 reports
- ELEOS™ 25001212EOnkos Surgical, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented33 reports
- ELEOS™ 25001220EOnkos Surgical, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented30 reports
- ELEOS™ 25002113EOnkos Surgical, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 death29 reports
- ELEOS™ 25001216EOnkos Surgical, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 death26 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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