Stem implants Recall: Onkos ELEOS Segmental Limb Salvage System
Announced 2025-09-03 · FDA
An unidentified substance of unknown impact was identified on Onkos ELEOS segmental limb salvage canal filling stem implants during a retrospective evaluation. The recall covers 30 units distributed nationwide in AK, AZ, CA, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, TN, TX, UT, WA, and WI. Model Nos. 2500BP20E and 2500BP22E; UDIs B2782500BP20E0 and B2782500BP22E0; all lots released prior to 2025-07-11 are included; no corrective action is specified.
| Brand | Onkos Surgical, Inc. |
|---|---|
| Product | ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal filling stem implants. |
| Reason | Unidentified substance of unknown impact was identified on devices during a retrospective evaluation. |
| Severity | moderate |
| Units affected | 554 |
| 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. |
| Agency | FDA |
| Recall / campaign no. | Model No. 2500BP20E, 2500BP22E; UDI: B2782500BP20E0, B2782500BP22E0; Lot No. All lots released prior to 2025-07-11. |
WHAT YOU SHOULD DO
- Check if you have an affected device by verifying model numbers 2500BP20E or 2500BP22E and the lot/UDI information.
- Contact your surgeon or hospital for guidance and do not remove or modify the implant yourself.
- Follow the FDA recall instructions and attend any recommended follow-up appointments.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.