FDA Medical devices recall ·
ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM… recall
- Recall number
- Z-1817-2025
- Date
- (initiated December 22, 2023)
- 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
- 23 units
- Hazard tags
- Mislabeling
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03M. Component of Limb Salvage System with BioGrip.
Why was it recalled?
Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that was 15mm in diameter (HC-15120-03M) instead of being 13mm as stated on the package. The corresponding 15mm cemented stems were mislabeled as size 13mm cemented stems.
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
Model Number: HC-13120-03M. UDI-DI: B278HC1312003M0. Serial Numbers: P230274-1XX (XX represents 23 parts in sequential order from 101-123).
Distribution
US Nationwide distribution in the states of California, Kentucky, and Wisconsin.
States: California Kentucky Wisconsin
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-1817-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.