Onkos Surgical recalls ELEOS Segmental Limb Salvage System implants due to unidentified substance found during evaluation. Affected units were sold before July 11, 2025. No specific action is required per recall notice.
Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
Onkos Surgical is recalling certain ELEOS Segmental Limb Salvage System implants because an unidentified substance was found during a retrospective evaluation. This recall does not require immediate action as the official notice states no specific remedy is needed.
The recall identifies an unidentified substance on the devices during a retrospective evaluation. However, the recall notice does not specify what this substance could do or how it might affect safety during use.
Patients who received the ELEOS Segmental Limb Salvage System implants with model number 2500CP16E and UDI B2782500CP16E0 before July 11, 2025, are likely affected. Medical professionals using these implants for limb salvage procedures are at risk.
Check for model number 2500CP16E and unique device identifier (UDI) B2782500CP16E0 on the implants. Products were sold before July 11, 2025, and all lots released prior to that date are affected.
Look for model number 2500CP16E and UDI B2782500CP16E0 on the implants to confirm if they are affected.
The recall notice states no specific action is required, so you do not need to stop using them.
The official recall notice does not specify any action steps, so no immediate action is needed.
The recall mentions an unidentified substance was found, but the notice does not describe any specific safety risks.
We’ve drafted a message you can send Onkos Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-2424-2025 — Onkos Surgical Onkos Surgical Hello, I own a Onkos Surgical that is covered by recall Z-2424-2025 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.
