Onkos Surgical, Inc. is recalling approximately 725 units of its ELEOS Limb Salvage System components due to a potential breach in the Tyvek sterile packaging seals. The recall affects several components including segmental stems (straight, bowed, and canal filling variants), collar stems, and midsections used in complex limb reconstruction surgeries. While no injuries or incidents have been reported, a compromise in sterile packaging means these surgical implants could become contaminated before use.
A breach in the sterile seal can expose surgical implants to bacteria and other contaminants, leading to a risk of serious surgical site infections. Because these devices are implanted into the body during major limb-salvage procedures, any loss of sterility could result in severe health complications for the patient.
Recall #: Z-1879-2025
Recall #: Z-1880-2025
Recall #: Z-1881-2025
Recall #: Z-1882-2025
Recall #: Z-1883-2025
Recall #: Z-1884-2025
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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