medical Class II Updated 2025-06-04

Onkos Surgical, Inc. recalls ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Nu

Recalled Product

ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03M. Component of Limb Salvage System with BioGrip.

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Model Number: HC-13120-03M. UDI-DI: B278HC1312003M0. Serial Numbers: P230274-1XX (XX represents 23 parts in sequential order from 101-123).
View official government recall

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