Recall Z-1818-2025 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Onkos Surgical, Inc.
ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03M. Component of Limb Salvage System with BioGrip.
| Date | May 23, 2025 (initiated Dec 22, 2023) |
| Status | Open, Classified |
| 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. |
| Root cause | Labeling Change Control |
| Action | ONKOS Surgical notified their distributors on about 12/22/2023 via email. They were instructed to segregate and quarantine the product immediately, complete and return the "Product and Distribution Information" form within 2 business days and return any existing implants on hand within 2 business days after signing the acknowledgement. They were also instructed that they will receive replacement implants and to place them in their modular segmental collar stem implant packs. |
| Quantity | 23 units |
| Distribution | US Nationwide distribution in the states of California, Kentucky, and Wisconsin. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K203815 | ELEOS Limb Salvage System with BioGrip Onkos Surgical, Jun 9, 2021 |