Recall Z-1879-2025 ยท KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Onkos Surgical, Inc.
a. Segmental Stem, Cemented, Straight, 100MM, 1 EACH; Model Numbers: CS-09100-03M, CS-10100-03M. b. Segmental Stem, Cemented, Straight, 120MM, 1 EACH. Model Numbers: CS-11120-03M, CS-13120-03M, CS-15120-03M, CS-17120-03M. Component. of ELEOS 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 | 147 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
| K161520 | ELEOS Limb Salvage System Onkos Surgical, Inc., Oct 28, 2016 |