Z-1857-2025 Class II Ongoing
FDA device recall Z-1857-2025 was initiated by Onkos Surgical, Inc. on September 22, 2024 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 24 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 4, 2025
- Initiation Date
- September 22, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24 units
Product Description
ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System
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.
Distribution Pattern
US Nationwide distribution in the states of AZ, CA, FL, FL, MD, MO, NC, TN.
Code Information
Part Number: 25001040E. UDI-DI B27825001040E0. Lot Numbers: 1989873, 1989874