Onkos Surgical recalls ELEOS Segmental Limb Salvage System and Bowed Canal Filling Stems due to unidentified substance found on devices. Affected models include 2500BP20E and 2500BP22E, produced before July 2025.
Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
Onkos Surgical is recalling ELEOS Segmental Limb Salvage System and Bowed Canal Filling Stems because an unidentified substance was found on some devices during testing. This could pose a risk if the substance causes complications after implantation, though the exact impact is unknown.
During a retrospective evaluation, an unidentified substance was found on some devices. The exact impact of this substance is unknown, but it could potentially cause complications if the device is implanted.
Patients who received the ELEOS Segmental Limb Salvage System or Bowed Canal Filling Stems implants between 2023 and July 2025 are likely affected. Those with implants containing the specific model numbers 2500BP20E or 2500BP22E are at risk.
Check if your implant has model numbers 2500BP20E or 2500BP22E. Devices were produced before July 11, 2025, and have unique identifiers starting with B2782500BP20E0 or B2782500BP22E0.
Look for model numbers 2500BP20E or 2500BP22E on your implant.
The recall states an unidentified substance was found on devices during testing, but the exact impact is unknown.
Check for model numbers 2500BP20E or 2500BP22E, and ensure it was produced before July 11, 2025.
The recall does not specify a remedy, so contact Onkos Surgical directly for guidance.
We’ve drafted a message you can send Onkos Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-2423-2025 — Onkos Surgical Onkos Surgical Hello, I own a Onkos Surgical that is covered by recall Z-2423-2025 from Onkos Surgical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
