Recall Z-2424-2025 · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Onkos Surgical, Inc.
ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS SEGMENTAL STEM CANAL FILLING STRAIGHT SLOTTED SPLINED 2/3 PLASMA. Canal filling stem implants.
| Date | Aug 25, 2025 (initiated Jul 11, 2025) |
| Status | Open, Classified |
| Reason | Unidentified substance of unknown impact was identified on devices during a retrospective evaluation. |
| Root cause | Under Investigation by firm |
| Action | An email dated 7/11/25 was sent to consignees notifying them of this recall. Distributors and sales personnel are to segregate and quarantine affected devices immediately and return a completed Product and Distribution Information Table to mdufner@onkossurgical.com. Affected devices are to be returned within two business days to Onkos Surgical. Consignees with any questions are to contact Matt Dufner with any questions at 267-566-4560 or mdufner@onkossurgical.com. An email dated 8/5/25 was sent to surgical consignees notifying them of this recall. Hospitals are to remove affected devices from |
| Quantity | 15 units |
| Distribution | US Nationwide distribution in the states of AK, AZ, CA, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, TN, TX, UT, WA & WI. |
| FDA record | Open on fda.gov |