Onkos Surgical, Inc. is recalling 599 units of its ELEOS Segmental Limb Salvage System implants after an unidentified substance was found on the devices during a retrospective evaluation. The recall includes canal filling stem implants and stem extensions released prior to July 11, 2025. Because these are surgical implants, consumers who have already received one of these devices should consult with their surgeon or healthcare provider regarding any concerns about their implant's performance or potential reactions.
The presence of an unidentified substance on a medical implant poses a risk of adverse tissue reactions, inflammation, or infection within the body. While the specific impact of the substance is currently unknown, its presence could compromise the biocompatibility or sterile integrity of the implanted device.
All lots released prior to 2025-07-11.
All lots released prior to 2025-07-11.
All lots released prior to 2025-07-11.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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