Onkos Surgical, Inc.: Device Recall
Recall #Z-1857-2025 · 09/22/2024
Class II: Risk
Recall Details
- Recall Number
- Z-1857-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Onkos Surgical, Inc.
- Status
- Ongoing
- Date Initiated
- 09/22/2024
- Location
- Parsippany, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24 units
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.
Product Description
ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System
Distribution Pattern
US Nationwide distribution in the states of AZ, CA, FL, FL, MD, MO, NC, TN.
Other Recalls by Onkos Surgical, Inc.
- Class II: Risk 07/11/2025
- Class II: Risk 07/11/2025
- Class II: Risk 07/11/2025
- Class II: Risk 05/20/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.