Onkos Surgical, Inc. has recalled approximately 46 units of its ELEOS Collar Stems, which are used as components in its Limb Salvage System. The recall was initiated because the packaging for 13mm Modular Segmental Stems (Model HC-13120-03M) mistakenly contained 15mm diameter implants (Model HC-15120-03M). Additionally, the 15mm cemented stems were mislabeled as 13mm size on the outer packaging. No injuries have been reported to date regarding this size discrepancy.
If a surgeon relies on the incorrect package label during a procedure, they may attempt to use an implant that does not fit the prepared site, leading to surgical delays or the need for additional procedures. Using an incorrectly sized orthopedic implant could also lead to poor joint stability or device failure over time.
Component of Limb Salvage System with BioGrip; Recall #: Z-1817-2025.
Component of Limb Salvage System with BioGrip; Recall #: Z-1818-2025.
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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