FDA Medical devices recall ·
ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E… recall
- Recall number
- Z-1857-2025
- Date
- (initiated September 22, 2024)
- Company / brand
- Onkos Surgical, Inc.
77 E Halsey Rd, Parsippany, NJ, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 24 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System
Why was it recalled?
Potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Part Number: 25001040E. UDI-DI B27825001040E0. Lot Numbers: 1989873, 1989874
Distribution
US Nationwide distribution in the states of AZ, CA, FL, FL, MD, MO, NC, TN.
States: Arizona California Florida Maryland Missouri North Carolina Tennessee
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1857-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.