FDA-Device2025-06-04Class II
ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03M. Component of Limb Salvage System with BioGrip.
Onkos Surgical, Inc.
Hazard
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.
Sold states
US Nationwide distribution in the states of California, Kentucky, and Wisconsin.
Affected count
23 units
Manufactured in
77 E Halsey Rd, N/A, Parsippany, NJ, United States
Products
ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03M. Component of Limb Salvage System with BioGrip.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1818-2025Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief