Stem implants Recall: Onkos ELEOS Segmental Limb Salvage System
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 |
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.
How to identify the recalled item
| Lot / date codes | Model No. 2500BP20E, 2500BP22E; UDI: B2782500BP20E0, B2782500BP22E0; Lot No. All lots released prior to 2025-07-11. |
|---|---|
| Lot / date codes | Model No. KSP17100E, KSP17140E, KSP18100E, KSP18140E, KSP20100E, KSP20140E, KSP22100E; UDI: B278KSP17100E0, B278KSP17140E0, B278KSP18100E0, B278KSP18140E0, B278KSP20100E0, B278KSP20140E0, B278KSP22100E0; Lot No. All lots released prior to 2025-07-11. |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
Other Onkos Surgical, Inc. recalls
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.