Onkos Surgical recalls ELEOS Segmental Limb Salvage System implants with unidentified substance. Affected models were sold before July 11, 2025. No remedy specified in recall notice.
Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
Onkos Surgical is recalling certain ELEOS limb salvage implants due to an unidentified substance found during testing. This could pose a risk if the substance causes complications during surgery. Affected products were sold before July 11, 2025.
The recall identifies an unidentified substance on the implants during testing. This substance could potentially cause complications during surgery if it interacts with the body or surgical tools. However, the exact risk is not specified in the recall notice.
Surgical patients who received the recalled ELEOS Segmental Limb Salvage System implants. Surgeons and hospitals using these implants before July 11, 2025 are most at risk.
Check for model numbers KSP17100E through KSP22100E on the implant packaging. Products were sold before July 11, 2025, and have unique identifiers starting with B278KSP.
Review the model number and unique identifier on the implant packaging to confirm if it matches the recalled models.
The recall states an unidentified substance was found on devices during testing, but the exact risk is not specified.
Check for model numbers KSP17100E through KSP22100E and unique identifiers starting with B278KSP. Products were sold before July 11, 2025.
The recall notice does not specify a remedy, so contact the manufacturer 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-2425-2025 — Onkos Surgical Onkos Surgical Hello, I own a Onkos Surgical that is covered by recall Z-2425-2025 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.
