Device product
ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03M. Component of Limb Salvage System with BioGrip.
Z-1817-2025
Product summary
- Event
- Event 96781
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 23 units
- Official record key
device-enforcement:Z-1817-2025
Official wording
Reason: 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.
Code information: Model Number: HC-13120-03M. UDI-DI: B278HC1312003M0. Serial Numbers: P230274-1XX (XX represents 23 parts in sequential order from 101-123).
Distribution pattern: US Nationwide distribution in the states of California, Kentucky, and Wisconsin.
Derived failure modes
-
Labeling or packaging
Mislabeling