Recall Z-1883-2025 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Onkos Surgical, Inc.
Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03M, HC-15120-03M, HC-17120-03M. Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM
| Date | May 29, 2025 (initiated Sep 1, 2023) |
| Status | Open, Classified |
| Reason | Potential for breach of Tyvek seals. |
| Root cause | Packaging change control |
| Action | Onkos Surgical began notifying consignees on about 09/01/2023 via email. Consignees were instructed to complete and return the response form providing the affected lot numbers being returned, coordinate the return of affected units, and to note that when placing these parts into totes, always place them flat. |
| Quantity | 233 units |
| Distribution | Product was shipped from Onkos' distribution in Olive Branch, MS to consignees in the following states: GA, TX, WA, LA, NJ, FL, AZ, MD, MS, KS, IL, WI, KY, PA, NC, NE, OH, HI. |
| 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 |